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\def\RunningAuthor{Aluri Nandini}
\firstPage{2005}
\articleType{Original Article}
\receivedDate{03 Feb 2021}
\acceptedDate{15 Mar 2021}
\revisedDate{08 Mar 2021}
\journalVolume{2021, 12}
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\journalDoi{ijrps.v12i3.4808}
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\title{\textbf{Process validation of sucralfate oral suspension}}
\author{Aluri~Nandini, 
            Ravi~G\textsuperscript{*}~\\[5pt]{Department of Pharmaceutics, MNR College of Pharmacy, Sangareddy-502294, Telangana, India}}

\begin{abstract}
Drugs are the critical elements in the health care system. They must be manufactured in the high-quality levels. End product testing by itself does not guarantee of the quality of the product. Quality assurance techniques must be used. In pharmaceutical industry, process validation performs this task, by ensuring that the process does what it purports to do. Validation is one of the important steps in achieving and maintaining the quality of the final product. If each step of production process is validated, we can assure that the final product is of the best quality. This study is intended to demonstrate and standardize the data that should be routinely included in the marketing authorization dossier describing evolution and validation of the manufacturing process and distinguish from the validation data which more properly fall under the remit of GMP inspection. During the study of critical process variables of sucralfate oral suspension were validated to demonstrate consistency of manufacturing process to produce the produce the product of desired quality. The validation studies were conducted which were intended for the use of commercial purpose so this validation study is concurrent type. All the in-process variables and finished product characteristics were monitored; the statistical analysis of data was carried out. Further from the results, it is inferred that the manufacturing process of sucralfate oral suspension was validated.
\end{abstract}\def\keywordstitle{Keywords}

\begin{keywords}Quality Assurance,\newline GMP,\newline Quality,\newline Suspension,\newline Validation
\end{keywords}
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\makeatletter{\raggedright\textsuperscript{*}Corresponding Author\par Name:\ Ravi~G~\\ Phone:\ 8073210963~\\  Email:\ ravigundawar1@gmail.com
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\section{Introduction}
According to USFDA ``Validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes. The concept of validation was first proposed by two Food and Drug Administration (FDA) officials, Ted Byers and Bud Loftus, in the mid 1970's in order to improve the quality of pharmaceuticals\unskip~\citep{1398192:24806897}. A validated process has been demonstrated to provide a high degree of assurance that uniform batches will consistently meets pre-determined specifications. Validation by itself does not improve processes but it confirms that the processes have been appropriately developed and are under control. If each step of process is validated, we can assure that the final product is of the best quality \unskip~\citep{1398192:24806890}. Adequate validation decreases the risk of defect costs, the risk of regulatory noncompliance and requires less in-process controls and end product testing. The concept of validation is to ensure a steady production of a quality product throughout its life cycle that includes the critical aspects of ICH Q8, Q9 and Q10 guidelines \unskip~\citep{1398192:24806893}.

The pharmaceutical process validation refers that it should cover all the critical parameters in a manufacturing process for a pharmaceutical dosage form, from designing a process to final validation of that


\begin{table*}[!htbp]
\caption{\boldmath {Critical process variables for the production of bulk suspension} }
\label{tw-e8d50f9f0860}
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\ignorespaces 
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\tbltoprule \rowcolor{kwdboxcolor}Critical process variable & Acceptance criteria & Observation & Result\\
\tblmidrule 
\multicolumn{4}{p{\dimexpr(1\linewidth-2\tabcolsep)}}{Preparation of bulk suspension}\\
Capacity &
  8000Ltr &
  8000Ltr &
  Complies\\
Mixing speed  &
  1000RPM &
  1000RPM &
  Complies\\
Mixing time &
  To be recorded &
  20 min &
  Complies\\
Process time &
  To be recorded &
  09:00(23/1/2020)to 12:30 (24/1/2020) &
  Complies\\
pH of purified water &
  4.50 to 7.00 &
  5.41 &
  Complies\\
Conductivity of purified water &
  NLT 5.1\ensuremath{\mu}s/cm &
  1.921\ensuremath{\mu}/cm &
  Complies\\
\multicolumn{4}{p{\dimexpr(1\linewidth-2\tabcolsep)}}{Filtration of bulk suspension}\\
Filter  &
  60 \# Nylon cloth &
  60 \# Nylon cloth &
  Complies\\
Filter start time &
  To be recorded &
  06:30(24/01/2020) &
  Complies\\
Filter end time &
  To be recorded &
  12:30(24/01/2020) &
  Complies\\
pH of bulk solution &
  4.00 to 6.00 &
  4.80 &
  Complies\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table}[!htbp]
\caption{\boldmath {Process parameter test results} }
\label{tw-28eaf67f4e82}
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\begin{tabulary}{\linewidth}{p{\dimexpr.11639999999999999\linewidth-2\tabcolsep}p{\dimexpr.27099999999999998\linewidth-2\tabcolsep}p{\dimexpr.2104\linewidth-2\tabcolsep}p{\dimexpr.2022\linewidth-2\tabcolsep}p{\dimexpr.20\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}S.no & Test & After 10 Min & After 15 Min & After 20 Min\\
\tblmidrule 
1 &
  Description &
  Complies &
  Complies &
  Complies\\
\tblbottomrule 
\end{tabulary}\par 
\end{table}

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\caption{\boldmath {Manufacturing process sucralfate oral suspension}}
\label{f-bb07d7933abd}
\end{figure}
\egroup

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\caption{\boldmath {Packaging process sucralfate oral suspension}}
\label{f-3ac2dfe0228a}
\end{figure}
\egroup
the formulation in the large-scale production \unskip~\citep{1398192:24806888,1398192:24806887}. FDA has the authority of responsibility to inspect and evaluate process validation performed by manufacturers \unskip~\citep{1398192:24806889}. The cGMP regulations for validating pharmaceutical (drug) manufacturing process quotes that drug products be produced requires a high degree of assurance for meeting all the predetermined specifications they are intended to meet (21 CFR 211.100(a) and 211.110) \unskip~\citep{1398192:24806886,1398192:24806885}.

Pharmaceutical suspension is a biphasic coarse dispersion in which internal phase (therapeutically active ingredient) is dispersed uniformly throughout the external phase\ensuremath{_{.}} Internal phase consisting of insoluble solid particles having a range of size (0.5to 5 microns) which maintained uniformly through the suspending vehicle with aid of single or combination of suspending agent and external phase (suspending medium) is generally aqueous in some instance, may be organic or oily liquid or non-oral use \unskip~\citep{1398192:24806898}.

The reasons for performing process validation are, to assure completely that all the manufacturing processes, procedures and machinery being used should ensure safety, quality and strength of that formulation. Validation is very eminent, if there are any prominent changes to the premises, the facilities, the process or the equipment which may interferes with the quality of that product, directly or


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\caption{\boldmath {Sampling Location} }
\label{tw-efbcf56a0c5a}
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\multicolumn{1}{p{\dimexpr(.04130000000000001\linewidth-2\tabcolsep)}}{\multirow{2}{\linewidth}{2}} &
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  \multicolumn{2}{p{\dimexpr(.125\linewidth-2\tabcolsep)}}{T2/10} &
  \multicolumn{2}{p{\dimexpr(.1167\linewidth-2\tabcolsep)}}{M1/10} &
  \multicolumn{2}{p{\dimexpr(.15979999999999997\linewidth-2\tabcolsep)}}{M2/10} &
  \multicolumn{2}{p{\dimexpr(.1636\linewidth-2\tabcolsep)}}{B/10}\\
 &
   &
   &
   &
   &
  \multicolumn{2}{p{\dimexpr(.08459999999999999\linewidth-2\tabcolsep)}}{4.94} &
  \multicolumn{2}{p{\dimexpr(.125\linewidth-2\tabcolsep)}}{4.92} &
  \multicolumn{2}{p{\dimexpr(.1167\linewidth-2\tabcolsep)}}{4.97} &
  \multicolumn{2}{p{\dimexpr(.15979999999999997\linewidth-2\tabcolsep)}}{4.95} &
  \multicolumn{2}{p{\dimexpr(.1636\linewidth-2\tabcolsep)}}{4.98}\\
 &
  Weight per ml &
  1.100- \mbox{}\protect\newline 1.400g/ml &
  \multicolumn{2}{p{\dimexpr(.10169999999999998\linewidth-2\tabcolsep)}}{} &
  \multicolumn{2}{p{\dimexpr(.08459999999999999\linewidth-2\tabcolsep)}}{1.2455g \mbox{}\protect\newline m/ml} &
  \multicolumn{2}{p{\dimexpr(.125\linewidth-2\tabcolsep)}}{1.2440g \mbox{}\protect\newline m/ml} &
  \multicolumn{2}{p{\dimexpr(.1167\linewidth-2\tabcolsep)}}{1.2451g \mbox{}\protect\newline m/ml} &
  \multicolumn{2}{p{\dimexpr(.15979999999999997\linewidth-2\tabcolsep)}}{1.2449g \mbox{}\protect\newline m/ml} &
  \multicolumn{2}{p{\dimexpr(.1636\linewidth-2\tabcolsep)}}{1.2468g \mbox{}\protect\newline m/ml}\\
\multicolumn{1}{p{\dimexpr(.04130000000000001\linewidth-2\tabcolsep)}}{\multirow{3}{\linewidth}{3}} &
  pH &
  4.00 to 6.00 &
  \multicolumn{2}{p{\dimexpr(.10169999999999998\linewidth-2\tabcolsep)}}{\multirow{3}{\linewidth}{After 15min}} &
  \multicolumn{2}{p{\dimexpr(.08459999999999999\linewidth-2\tabcolsep)}}{T1/15} &
  \multicolumn{2}{p{\dimexpr(.125\linewidth-2\tabcolsep)}}{T2/15} &
  \multicolumn{2}{p{\dimexpr(.1167\linewidth-2\tabcolsep)}}{M1/15} &
  \multicolumn{2}{p{\dimexpr(.15979999999999997\linewidth-2\tabcolsep)}}{M2/15} &
  \multicolumn{2}{p{\dimexpr(.1636\linewidth-2\tabcolsep)}}{B/15}\\
 &
  \multicolumn{1}{p{\dimexpr(.11029999999999998\linewidth-2\tabcolsep)}}{\multirow{2}{\linewidth}{Weight per ml}} &
  \multicolumn{1}{p{\dimexpr(.09700000000000003\linewidth-2\tabcolsep)}}{\multirow{2}{\linewidth}{1.100-1.400g/ml}} &
   &
   &
  \multicolumn{2}{p{\dimexpr(.08459999999999999\linewidth-2\tabcolsep)}}{4.92} &
  \multicolumn{2}{p{\dimexpr(.125\linewidth-2\tabcolsep)}}{4.96} &
  \multicolumn{2}{p{\dimexpr(.1167\linewidth-2\tabcolsep)}}{4.95} &
  \multicolumn{2}{p{\dimexpr(.15979999999999997\linewidth-2\tabcolsep)}}{4.98} &
  \multicolumn{2}{p{\dimexpr(.1636\linewidth-2\tabcolsep)}}{4.97}\\
 &
   &
   &
   &
   &
  \multicolumn{2}{p{\dimexpr(.08459999999999999\linewidth-2\tabcolsep)}}{1.2374 gm/ml} &
  \multicolumn{2}{p{\dimexpr(.125\linewidth-2\tabcolsep)}}{1.2454 gm/ml} &
  \multicolumn{2}{p{\dimexpr(.1167\linewidth-2\tabcolsep)}}{1.2488 gm/ml} &
  \multicolumn{2}{p{\dimexpr(.15979999999999997\linewidth-2\tabcolsep)}}{1.2464 gm/ml} &
  \multicolumn{2}{p{\dimexpr(.1636\linewidth-2\tabcolsep)}}{1.2463 gm/ml}\\
\multicolumn{1}{p{\dimexpr(.04130000000000001\linewidth-2\tabcolsep)}}{\multirow{2}{\linewidth}{4}} &
  pH &
  4.00 to 6.00 &
  \multicolumn{2}{p{\dimexpr(.10169999999999998\linewidth-2\tabcolsep)}}{\multirow{3}{\linewidth}{After 20min}} &
  \multicolumn{2}{p{\dimexpr(.08459999999999999\linewidth-2\tabcolsep)}}{T1/20} &
  \multicolumn{2}{p{\dimexpr(.125\linewidth-2\tabcolsep)}}{T2/20} &
  \multicolumn{2}{p{\dimexpr(.1167\linewidth-2\tabcolsep)}}{M1/20} &
  \multicolumn{2}{p{\dimexpr(.15979999999999997\linewidth-2\tabcolsep)}}{M2/20} &
  \multicolumn{2}{p{\dimexpr(.1636\linewidth-2\tabcolsep)}}{B/20 \mbox{}\protect\newline }\\
 &
  \multicolumn{1}{p{\dimexpr(.11029999999999998\linewidth-2\tabcolsep)}}{\multirow{2}{\linewidth}{Weight per ml}} &
  \multicolumn{1}{p{\dimexpr(.09700000000000003\linewidth-2\tabcolsep)}}{\multirow{2}{\linewidth}{1.100-1.400g/ml}} &
   &
   &
  \multicolumn{2}{p{\dimexpr(.08459999999999999\linewidth-2\tabcolsep)}}{5.00} &
  \multicolumn{2}{p{\dimexpr(.125\linewidth-2\tabcolsep)}}{4.97} &
  \multicolumn{2}{p{\dimexpr(.1167\linewidth-2\tabcolsep)}}{4.95} &
  \multicolumn{2}{p{\dimexpr(.15979999999999997\linewidth-2\tabcolsep)}}{4.98} &
  \multicolumn{2}{p{\dimexpr(.1636\linewidth-2\tabcolsep)}}{4.97}\\
 &
   &
   &
   &
   &
  \multicolumn{2}{p{\dimexpr(.08459999999999999\linewidth-2\tabcolsep)}}{1.2439 gm/ml} &
  \multicolumn{2}{p{\dimexpr(.125\linewidth-2\tabcolsep)}}{1.2465gm/ml} &
  \multicolumn{2}{p{\dimexpr(.1167\linewidth-2\tabcolsep)}}{1.2461 gm/ml} &
  \multicolumn{2}{p{\dimexpr(.15979999999999997\linewidth-2\tabcolsep)}}{1.2475 gm/ml} &
  \multicolumn{2}{p{\dimexpr(.1636\linewidth-2\tabcolsep)}}{1.2477 gm/ml}\\
\multicolumn{15}{p{\dimexpr(1\linewidth-2\tabcolsep)}}{Assay\% }\\
5 &
  \multicolumn{3}{p{\dimexpr(.2568\linewidth-2\tabcolsep)}}{After 10 min} &
  \multicolumn{2}{p{\dimexpr(.09339999999999998\linewidth-2\tabcolsep)}}{T1/10} &
  \multicolumn{2}{p{\dimexpr(.1267\linewidth-2\tabcolsep)}}{T2/10} &
  \multicolumn{2}{p{\dimexpr(.1178\linewidth-2\tabcolsep)}}{M1/10} &
  \multicolumn{2}{p{\dimexpr(.1537\linewidth-2\tabcolsep)}}{M2/10} &
  \multicolumn{2}{p{\dimexpr(.1382\linewidth-2\tabcolsep)}}{B/10} &
  RSD NMT 2\%\\
a &
  Sucralfate IP &
  \multicolumn{2}{p{\dimexpr(.14650000000000002\linewidth-2\tabcolsep)}}{NLT 0.950gm and  \mbox{}\protect\newline NMT1.050g \mbox{}\protect\newline (NLT95.00\% and  \mbox{}\protect\newline NMT105.00\% of  \mbox{}\protect\newline label claimed)} &
  \multicolumn{2}{p{\dimexpr(.09339999999999998\linewidth-2\tabcolsep)}}{0.9914gm \mbox{}\protect\newline 99.14\%} &
  \multicolumn{2}{p{\dimexpr(.1267\linewidth-2\tabcolsep)}}{0.9858g \mbox{}\protect\newline 98.58\%} &
  \multicolumn{2}{p{\dimexpr(.1178\linewidth-2\tabcolsep)}}{0.9928g \mbox{}\protect\newline 98.95\%} &
  \multicolumn{2}{p{\dimexpr(.1537\linewidth-2\tabcolsep)}}{0.9895 \mbox{}\protect\newline 97.40\%} &
  \multicolumn{2}{p{\dimexpr(.1382\linewidth-2\tabcolsep)}}{0.9907\%  \mbox{}\protect\newline } &
    0.27\%\\
b &
  Oxetacaine BP &
  \multicolumn{2}{p{\dimexpr(.14650000000000002\linewidth-2\tabcolsep)}}{NLT 9.50gm and NMT1.10.50gm \mbox{}\protect\newline (NLT95.00\%and  \mbox{}\protect\newline NMT105.00\% of  \mbox{}\protect\newline label claimed)} &
  \multicolumn{2}{p{\dimexpr(.09339999999999998\linewidth-2\tabcolsep)}}{9.71mg \mbox{}\protect\newline 97.10\%} &
  \multicolumn{2}{p{\dimexpr(.1267\linewidth-2\tabcolsep)}}{9.70mg \mbox{}\protect\newline 97.00\%} &
  \multicolumn{2}{p{\dimexpr(.1178\linewidth-2\tabcolsep)}}{9.72mg \mbox{}\protect\newline 97.20 \mbox{}\protect\newline } &
  \multicolumn{2}{p{\dimexpr(.1537\linewidth-2\tabcolsep)}}{9.74mg \mbox{}\protect\newline 97.40\%} &
  \multicolumn{2}{p{\dimexpr(.1382\linewidth-2\tabcolsep)}}{9.69 \mbox{}\protect\newline 96.90} &
  1.11\%\\
6 &
  \multicolumn{3}{p{\dimexpr(.2568\linewidth-2\tabcolsep)}}{After 15 min} &
  \multicolumn{2}{p{\dimexpr(.09339999999999998\linewidth-2\tabcolsep)}}{T1/15} &
  \multicolumn{2}{p{\dimexpr(.1267\linewidth-2\tabcolsep)}}{T2/15} &
  \multicolumn{2}{p{\dimexpr(.1178\linewidth-2\tabcolsep)}}{M1/15} &
  \multicolumn{2}{p{\dimexpr(.1537\linewidth-2\tabcolsep)}}{M2/15} &
  \multicolumn{2}{p{\dimexpr(.1382\linewidth-2\tabcolsep)}}{B/15} &
  RSD NMT 2\%\\
a &
  Sucralfate &
  \multicolumn{2}{p{\dimexpr(.14650000000000002\linewidth-2\tabcolsep)}}{NLT o.950gm and NMT1.050gm \mbox{}\protect\newline (NL} &
  \multicolumn{2}{p{\dimexpr(.09339999999999998\linewidth-2\tabcolsep)}}{0.9731gm} &
  \multicolumn{2}{p{\dimexpr(.1267\linewidth-2\tabcolsep)}}{0.9769gm} &
  \multicolumn{2}{p{\dimexpr(.1178\linewidth-2\tabcolsep)}}{0.9799gm} &
  \multicolumn{2}{p{\dimexpr(.1537\linewidth-2\tabcolsep)}}{0.9799gm} &
  \multicolumn{2}{p{\dimexpr(.1382\linewidth-2\tabcolsep)}}{0,9945gm} &
  0.82\%\\
 &
  e IP &
  \multicolumn{2}{p{\dimexpr(.14650000000000002\linewidth-2\tabcolsep)}}{T95.00\%and NMT \mbox{}\protect\newline 105.00\% of label  \mbox{}\protect\newline claimed)} &
  \multicolumn{2}{p{\dimexpr(.09339999999999998\linewidth-2\tabcolsep)}}{97.31\%} &
  \multicolumn{2}{p{\dimexpr(.1267\linewidth-2\tabcolsep)}}{97.69\%} &
  \multicolumn{2}{p{\dimexpr(.1178\linewidth-2\tabcolsep)}}{97.99\%} &
  \multicolumn{2}{p{\dimexpr(.1537\linewidth-2\tabcolsep)}}{97.99\%} &
  \multicolumn{2}{p{\dimexpr(.1382\linewidth-2\tabcolsep)}}{99.45\%} &
  \\
b &
  Oxetacaine BP &
  \multicolumn{2}{p{\dimexpr(.14650000000000002\linewidth-2\tabcolsep)}}{NLT 9.50gm and NMT1.10.50gm \mbox{}\protect\newline (NLT95.00\% and  \mbox{}\protect\newline NMT105.00\% of  \mbox{}\protect\newline label claimed)} &
  \multicolumn{2}{p{\dimexpr(.09339999999999998\linewidth-2\tabcolsep)}}{9.70mg \mbox{}\protect\newline 97.00\%} &
  \multicolumn{2}{p{\dimexpr(.1267\linewidth-2\tabcolsep)}}{9.71mg \mbox{}\protect\newline 97.10\%} &
  \multicolumn{2}{p{\dimexpr(.1178\linewidth-2\tabcolsep)}}{9.72mg \mbox{}\protect\newline 97.20\%} &
  \multicolumn{2}{p{\dimexpr(.1537\linewidth-2\tabcolsep)}}{9.70mg \mbox{}\protect\newline 97.00\%} &
  \multicolumn{2}{p{\dimexpr(.1382\linewidth-2\tabcolsep)}}{9.57mg \mbox{}\protect\newline 95.70\%} &
  1.11\%\\
7 &
  \multicolumn{3}{p{\dimexpr(.2568\linewidth-2\tabcolsep)}}{After 20 min} &
  \multicolumn{2}{p{\dimexpr(.09339999999999998\linewidth-2\tabcolsep)}}{T1/20} &
  \multicolumn{2}{p{\dimexpr(.1267\linewidth-2\tabcolsep)}}{T2/20} &
  \multicolumn{2}{p{\dimexpr(.1178\linewidth-2\tabcolsep)}}{M1/20} &
  \multicolumn{2}{p{\dimexpr(.1537\linewidth-2\tabcolsep)}}{M2/20} &
  \multicolumn{2}{p{\dimexpr(.1382\linewidth-2\tabcolsep)}}{B/20} &
  RSD NMT 2\%\\
a &
  Sucralfate IP &
  \multicolumn{2}{p{\dimexpr(.14650000000000002\linewidth-2\tabcolsep)}}{NLT o.950gm and NMT1.050gm \mbox{}\protect\newline (NLT95.00\%and  \mbox{}\protect\newline NMT105.00\% of  \mbox{}\protect\newline label claimed)} &
  \multicolumn{2}{p{\dimexpr(.09339999999999998\linewidth-2\tabcolsep)}}{0.9745gm \mbox{}\protect\newline 97.45\%} &
  \multicolumn{2}{p{\dimexpr(.1267\linewidth-2\tabcolsep)}}{0.9779gm \mbox{}\protect\newline 97.79\%} &
  \multicolumn{2}{p{\dimexpr(.1178\linewidth-2\tabcolsep)}}{0.9709gm \mbox{}\protect\newline 97.09\%} &
  \multicolumn{2}{p{\dimexpr(.1537\linewidth-2\tabcolsep)}}{0.9928gm \mbox{}\protect\newline 99.28\%} &
  \multicolumn{2}{p{\dimexpr(.1382\linewidth-2\tabcolsep)}}{0.9750gm \mbox{}\protect\newline 97.50\%} &
  1.22\%\\
b &
  Oxetacaine BP &
  \multicolumn{2}{p{\dimexpr(.14650000000000002\linewidth-2\tabcolsep)}}{NLT 9.50gm and NMT1.10.50gm \mbox{}\protect\newline (NLT95.00\%and  \mbox{}\protect\newline NMT105.00\% of  \mbox{}\protect\newline label claimed)} &
  \multicolumn{2}{p{\dimexpr(.09339999999999998\linewidth-2\tabcolsep)}}{9.72mg \mbox{}\protect\newline 97.20\%} &
  \multicolumn{2}{p{\dimexpr(.1267\linewidth-2\tabcolsep)}}{9.71mg \mbox{}\protect\newline 97.10\%} &
  \multicolumn{2}{p{\dimexpr(.1178\linewidth-2\tabcolsep)}}{9.72mg \mbox{}\protect\newline 97.20\%} &
  \multicolumn{2}{p{\dimexpr(.1537\linewidth-2\tabcolsep)}}{9.71mg \mbox{}\protect\newline 97.10\%} &
  \multicolumn{2}{p{\dimexpr(.1382\linewidth-2\tabcolsep)}}{9.61mg \mbox{}\protect\newline 96.10\%} &
  0.48\%\\
\tblbottomrule 
\end{longtable}
\endgroup
\makeatletter\@ifundefined{TwoColDocument}{}{\twocolumn}\makeatother 

\begin{table}[!htbp]
\caption{\boldmath {Environmental monitoring of manufacturing area} }
\label{tw-845b3f25ebe2}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.5551\linewidth-2\tabcolsep}p{\dimexpr.1503\linewidth-2\tabcolsep}p{\dimexpr.17110000000000003\linewidth-2\tabcolsep}p{\dimexpr.1235\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}Parameter & \multicolumn{3}{p{\dimexpr(.4449\linewidth-2\tabcolsep)}}{\cAlignHack Results}\\
\rowcolor{kwdboxcolor} & Initial & Middle & End\\
\tblmidrule 
Temperature NMT 25\text{\textordmasculine}C &
  22.1 \text{\textordmasculine}C &
  20.5 \text{\textordmasculine}C &
  20.5 \text{\textordmasculine}C\\
Differential pressure of air Lock I~should be  &
  10pa &
  8pa &
  10pa\\
between (6-12pascal) &
   &
   &
  \\
Differential pressure of manufacturing room between (12-13pascal) &
  18pa &
  20pa &
  22pa\\
Differential pressure of bulk holding area between (12-30pascals) &
  10pa &
  10pa &
  20pa\\
\tblbottomrule 
\end{tabulary}\par 
\end{table}

\begin{table}[!htbp]
\caption{\boldmath {Yield statement of bulk suspension} }
\label{tw-3ba1736b9f6c}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.1785\linewidth-2\tabcolsep}p{\dimexpr.4815\linewidth-2\tabcolsep}p{\dimexpr.34\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}S.No & Step & Yield \%\\
\tblmidrule 
1 &
  Bulk  &
  5000.00lit\\
2 &
  Filtration  &
  4990.00lit\\
3 &
  Percentage yield  &
  99.86\%\\
\tblbottomrule 
\end{tabulary}\par 
\end{table}

\begin{table}[!htbp]
\caption{\boldmath {PET bottle washing} }
\label{tw-7522e6751dc7}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.3922\linewidth-2\tabcolsep}p{\dimexpr.3943\linewidth-2\tabcolsep}p{\dimexpr.21349999999999998\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}Parameter & Limit & Result\\
\tblmidrule 
Temperature &
  NMT 25\text{\textordmasculine}C &
  21.1\text{\textordmasculine}C\\
Washing machine speed &
  60 {\textendash} 100 bottles per min &
  60-100BPM\\
Air pressure &
  1.3kg/cm\ensuremath{^2} &
  1.3kg/cm\ensuremath{^2}\\
Purified water &
  1.3kg/cm\ensuremath{^2} &
  1.3kg/cm\ensuremath{^2}\\
\tblbottomrule 
\end{tabulary}\par 
\end{table}

\begin{table}[!htbp]
\caption{\boldmath {Filling operation} }
\label{tw-2777da23a85e}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.3217\linewidth-2\tabcolsep}p{\dimexpr.4275000000000001\linewidth-2\tabcolsep}p{\dimexpr.2508\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}Parameter & Limit & Observation\\
\tblmidrule 
Temperature  &
  NMT25\text{\textordmasculine}C &
  21.9\text{\textordmasculine}C\\
Intended fill volume &
  200ml {\textendash} 202ml &
  Min 200ml  \mbox{}\protect\newline Max 202ml\\
Filling/C speed &
  60 to 100 bottles/min &
  60 to 100 bottles/min\\
Leak test &
  No leakage should be absorbed  &
  Found ok\\
\tblbottomrule 
\end{tabulary}\par 
\end{table}

\begin{table}[!htbp]
\caption{\boldmath {Process variable results for packaging} }
\label{tw-bb8dc171e6e2}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.17009999999999998\linewidth-2\tabcolsep}p{\dimexpr.1967\linewidth-2\tabcolsep}p{\dimexpr.2332\linewidth-2\tabcolsep}p{\dimexpr.24490000000000002\linewidth-2\tabcolsep}p{\dimexpr.1551\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}Process Step & Euipment Name & Critical Process Variable  & Acceptance Criteria & Result\\
\tblmidrule 
\multicolumn{1}{p{\dimexpr(.17009999999999998\linewidth-2\tabcolsep)}}{\multirow{6}{\linewidth}{Filling and sealing}} &
  \multicolumn{1}{p{\dimexpr(.1967\linewidth-2\tabcolsep)}}{\multirow{6}{\linewidth}{Filling and sealing machine }} &
  Process time &
  To recorded &
  09:56hrs\\
 &
   &
  Machine speed &
  60to100 BPM &
  82BPM\\
 &
   &
  Average fill volume &
  NLT200ml &
  201.2ml\\
 &
   &
  Uniformity of fill volume &
  NLT 191.0ml and NMT 209.0ml &
  Min {\textendash} 200ml \mbox{}\protect\newline Max {\textendash} 202ml\\
 &
   &
  Quality of sealing &
  Should be proper &
  Found ok\\
 &
   &
  pH of finished products &
  4.00 - 6.00 &
  4.91\\
\tblbottomrule 
\end{tabulary}\par 
\end{table}

\begin{table*}[!htbp]
\caption{\boldmath {In process product analysis during filling and sealing } }
\label{tw-52eec559b856}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.22330000000000002\linewidth-2\tabcolsep}p{\dimexpr.24799999999999997\linewidth-2\tabcolsep}p{\dimexpr.18179999999999996\linewidth-2\tabcolsep}p{\dimexpr.17680000000000007\linewidth-2\tabcolsep}p{\dimexpr.17009999999999998\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}Test  & Limit  & \multicolumn{3}{p{\dimexpr(.5287\linewidth-2\tabcolsep)}}{\cAlignHack Result}\\
\rowcolor{kwdboxcolor} &  & Initial  & Middle  & End \\
\tblmidrule 
Description &
  White to off white,flavored homogenous suspension &
  Compile  &
  Compile  &
  Compile \\
Ph &
  Between 4.00 and 6.00 &
  5.01 &
  4.98 &
  5.03\\
Weight by ml &
  Between 1.100 and 1.400gm/ml &
  1.2375gm/ml &
  1.2425g/ml &
  1.2451gm/ml\\
Average net volume &
  NLT200.0ml &
  201.2ml &
  200.8ml &
  201.0ml\\
Uniformity of fill volume &
  Within \ensuremath{\pm} 4.5\% of average fill volume   &
  Min 200 ml \mbox{}\protect\newline Max 202ml &
  Min 200 ml \mbox{}\protect\newline Max 202ml &
  Min 200 ml \mbox{}\protect\newline Max 202ml\\
\multicolumn{5}{p{\dimexpr(1\linewidth-2\tabcolsep)}}{Assay: each 5ml contains}\\
Sucralfate IP &
  NLT 0.950gm and NMT 1.050gm(NLT 95.00\% and NMT105.00\%)  &
  1.0108gm \mbox{}\protect\newline 101.08\% &
  1.0133gm \mbox{}\protect\newline 101.33\% &
  1.0202gm \mbox{}\protect\newline 102.02\%\\
 &
  of label claimed NLT0 &
   &
   &
  \\
Oxetacaine BP &
  NLT 9.50gm and NMT 10.50gm(NLT 95.00\% and NMT 105.00\%) of label claimed &
  9.72mg \mbox{}\protect\newline 97.20\% &
  9.76mg \mbox{}\protect\newline 97.60\% &
  9.72mg \mbox{}\protect\newline 97.20\%\\
\multicolumn{5}{p{\dimexpr(1\linewidth-2\tabcolsep)}}{Total aerobic bacterial count}\\
Total aerobic bacterial count &
  NMT100CFU/ml &
  {\textless}10cfu/ml &
  {\textless}10cfu/ml &
  {\textless}10cfu/ml\\
Total combined yeast and mould count &
  NMT 10 CFU/ml &
  10cfu/ml &
  {\textless}10cfu/ml &
  {\textless}10cfu/ml\\
\multicolumn{5}{p{\dimexpr(1\linewidth-2\tabcolsep)}}{Pathogens :}\\
E.coli &
  Should be absent/ml &
  Absent  &
  Absent  &
  Absent \\
Salmonella spices &
  Should be absent/10ml &
  Absent  &
  Absent  &
  Absent \\
Staphylococcus aurous &
  Should be absent/ml &
  Absent  &
  Absent  &
  Absent \\
Pseudomonas aeruginosa  &
  Should be absent/ml &
  Absent  &
  Absent  &
  Absent \\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Environmental monitoring of filling and sealing area} }
\label{tw-625373cce483}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.5675\linewidth-2\tabcolsep}p{\dimexpr.14629999999999997\linewidth-2\tabcolsep}p{\dimexpr.138\linewidth-2\tabcolsep}p{\dimexpr.1482\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}Parameter & \multicolumn{3}{p{\dimexpr(.4325\linewidth-2\tabcolsep)}}{\cAlignHack Result}\\
\rowcolor{kwdboxcolor} & Initial & Middle & End\\
\tblmidrule 
Temperature NMT 25\text{\textordmasculine}C &
  22.1 \text{\textordmasculine}C &
  22.2\text{\textordmasculine}C &
  20.5 \text{\textordmasculine}C\\
Differential pressure of air Lock I~should be between (6-12pascal) &
  4pa &
  4pa &
  4pa\\
Differential pressure of manufacturing room between (12-13pascal) &
  10pa &
  8pa &
  10pa\\
Differential pressure of bulk holding area between (12-30pascals) &
  18pa &
  22pa &
  20pa\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Finished product analysis} }
\label{tw-c0332f7eda43}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.09219999999999999\linewidth-2\tabcolsep}p{\dimexpr.15450000000000001\linewidth-2\tabcolsep}p{\dimexpr.06799999999999997\linewidth-2\tabcolsep}p{\dimexpr.4595\linewidth-2\tabcolsep}p{\dimexpr.05900000000000001\linewidth-2\tabcolsep}p{\dimexpr.1668\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}S.No & Test & \multicolumn{2}{p{\dimexpr(.5275\linewidth-2\tabcolsep)}}{\cAlignHack Acceptance Criteria} & \multicolumn{2}{p{\dimexpr(.22580000000000002\linewidth-2\tabcolsep)}}{\cAlignHack Results}\\
\tblmidrule 
1 &
  Description  &
  \multicolumn{2}{p{\dimexpr(.5275\linewidth-2\tabcolsep)}}{White to off white, flavored homogenous suspension} &
  \multicolumn{2}{p{\dimexpr(.22580000000000002\linewidth-2\tabcolsep)}}{Complies }\\
2 &
  pH &
  \multicolumn{2}{p{\dimexpr(.5275\linewidth-2\tabcolsep)}}{Between 4.00 and 6.00} &
  \multicolumn{2}{p{\dimexpr(.22580000000000002\linewidth-2\tabcolsep)}}{4.91}\\
3 &
  \multicolumn{5}{p{\dimexpr(.9078\linewidth-2\tabcolsep)}}{Identification by HPLC}\\
A &
  \multicolumn{2}{p{\dimexpr(.2225\linewidth-2\tabcolsep)}}{For sucralfate} &
  In the assay, the retention time of the principle peak in the chromatogram obtained with the test solution corresponding to the peak in the chromatogram obtained with the standard  &
  \multicolumn{2}{p{\dimexpr(.22580000000000002\linewidth-2\tabcolsep)}}{Complies }\\
 &
  \multicolumn{2}{p{\dimexpr(.2225\linewidth-2\tabcolsep)}}{} &
  solution &
  \multicolumn{2}{p{\dimexpr(.22580000000000002\linewidth-2\tabcolsep)}}{}\\
B &
  \multicolumn{2}{p{\dimexpr(.2225\linewidth-2\tabcolsep)}}{For Oxetacaine} &
  In the assay, the retention time of the principle peak in the chromatogram obtained with the test solution corresponding to the peak in the chromatogram obtained with the standard solution &
  \multicolumn{2}{p{\dimexpr(.22580000000000002\linewidth-2\tabcolsep)}}{Complies }\\
C &
  \multicolumn{2}{p{\dimexpr(.2225\linewidth-2\tabcolsep)}}{For sodium benzoate } &
  In the assay, the retention time of the principle peak in the chromatogram obtained with the test solution corresponding to the peak in the chromatogram obtained with the standard solution &
  \multicolumn{2}{p{\dimexpr(.22580000000000002\linewidth-2\tabcolsep)}}{Complies}\\
4 &
  \multicolumn{2}{p{\dimexpr(.2225\linewidth-2\tabcolsep)}}{For aluminum} &
  White precipitate formation &
  \multicolumn{2}{p{\dimexpr(.22580000000000002\linewidth-2\tabcolsep)}}{Complies}\\
5 &
  \multicolumn{2}{p{\dimexpr(.2225\linewidth-2\tabcolsep)}}{Weigh per /ml} &
  Between 1.1000and 1.400gm/ml &
  \multicolumn{2}{p{\dimexpr(.22580000000000002\linewidth-2\tabcolsep)}}{1.24gm/ml}\\
6 &
  \multicolumn{2}{p{\dimexpr(.2225\linewidth-2\tabcolsep)}}{Deliverable volume} &
  NLT 200.0ml &
  \multicolumn{2}{p{\dimexpr(.22580000000000002\linewidth-2\tabcolsep)}}{200ml}\\
7  &
  \multicolumn{2}{p{\dimexpr(.2225\linewidth-2\tabcolsep)}}{Average fill volume} &
  \ensuremath{\pm}4.5\%(191.0ml to 2090ml) &
  \multicolumn{2}{p{\dimexpr(.22580000000000002\linewidth-2\tabcolsep)}}{201.2ml}\\
8 &
  \multicolumn{2}{p{\dimexpr(.2225\linewidth-2\tabcolsep)}}{Uniformity fill volume} &
  Within \ensuremath{\pm}4.5\%of average fill volume &
  \multicolumn{2}{p{\dimexpr(.22580000000000002\linewidth-2\tabcolsep)}}{-0.6\%to+104\%}\\
9 &
  \multicolumn{2}{p{\dimexpr(.2225\linewidth-2\tabcolsep)}}{Acid neutralizing capacity} &
  NLT 12mEq/5ml &
  \multicolumn{2}{p{\dimexpr(.22580000000000002\linewidth-2\tabcolsep)}}{12.73mEq/5ml}\\
10 &
  \multicolumn{2}{p{\dimexpr(.2225\linewidth-2\tabcolsep)}}{Aluminum content} &
  NLT15.5\% and NMT18.5\% &
  \multicolumn{2}{p{\dimexpr(.22580000000000002\linewidth-2\tabcolsep)}}{16.5\%}\\
11 &
  \multicolumn{5}{p{\dimexpr(.9078\linewidth-2\tabcolsep)}}{Related substances by HPLC}\\
A &
  \multicolumn{2}{p{\dimexpr(.2225\linewidth-2\tabcolsep)}}{Single maximum impurity} &
  \multicolumn{2}{p{\dimexpr(.5185\linewidth-2\tabcolsep)}}{NMT0.5\%} &
  0.02\%\\
B &
  \multicolumn{2}{p{\dimexpr(.2225\linewidth-2\tabcolsep)}}{Total impurities} &
  \multicolumn{2}{p{\dimexpr(.5185\linewidth-2\tabcolsep)}}{NMT2.0\%} &
  0.09\%\\
12 &
  \multicolumn{5}{p{\dimexpr(.9078\linewidth-2\tabcolsep)}}{Assay: each 5ml contains:}\\
A &
  \multicolumn{2}{p{\dimexpr(.2225\linewidth-2\tabcolsep)}}{Sucralfate IP} &
  \multicolumn{2}{p{\dimexpr(.5185\linewidth-2\tabcolsep)}}{NLT 0.950gm and NMT 1.050gm(NLT 95.00\% and NMT105.00\%) of label claimed} &
  0.987gm \mbox{}\protect\newline 98.7\%\\
B &
  \multicolumn{2}{p{\dimexpr(.2225\linewidth-2\tabcolsep)}}{Oxetacaine BP} &
  \multicolumn{2}{p{\dimexpr(.5185\linewidth-2\tabcolsep)}}{NLT 9.50gm and NMT 10.50gm(NLT 95.00\% and NMT 105.00\%) of label claimed} &
  9.79mg \mbox{}\protect\newline 97.10\%\\
C &
  \multicolumn{2}{p{\dimexpr(.2225\linewidth-2\tabcolsep)}}{Sodium benzoate IP12.5mg} &
  \multicolumn{2}{p{\dimexpr(.5185\linewidth-2\tabcolsep)}}{NLT 10.00gm and NMT 15.00gm(NLT 80.00\% and NMT120.00\%) of  label claimed} &
  10.91mg \mbox{}\protect\newline 87.3\%\\
13 &
  \multicolumn{5}{p{\dimexpr(.9078\linewidth-2\tabcolsep)}}{Total aerobic bacterial count}\\
A &
  \multicolumn{2}{p{\dimexpr(.2225\linewidth-2\tabcolsep)}}{Total aerobic bacterial count} &
  \multicolumn{2}{p{\dimexpr(.5185\linewidth-2\tabcolsep)}}{NMT100cfu/ml} &
  {\textless}10cfu/ml\\
B &
  \multicolumn{2}{p{\dimexpr(.2225\linewidth-2\tabcolsep)}}{Total combined yeast and mould count} &
  \multicolumn{2}{p{\dimexpr(.5185\linewidth-2\tabcolsep)}}{NMT 10 cfu/ml} &
  {\textless}10cfu/ml\\
14 &
  \multicolumn{5}{p{\dimexpr(.9078\linewidth-2\tabcolsep)}}{Pathogens}\\
A &
  \multicolumn{2}{p{\dimexpr(.2225\linewidth-2\tabcolsep)}}{E.coli} &
  \multicolumn{2}{p{\dimexpr(.5185\linewidth-2\tabcolsep)}}{Should be absent/ml} &
  Absent /ml\\
B &
  \multicolumn{2}{p{\dimexpr(.2225\linewidth-2\tabcolsep)}}{Salmonella spices} &
  \multicolumn{2}{p{\dimexpr(.5185\linewidth-2\tabcolsep)}}{Should be absent/10ml} &
  Absent/10ml\\
c &
  \multicolumn{2}{p{\dimexpr(.2225\linewidth-2\tabcolsep)}}{Staphylococcus } &
  \multicolumn{2}{p{\dimexpr(.5185\linewidth-2\tabcolsep)}}{Should be absent/ml} &
  Absent /ml\\
 &
  \multicolumn{2}{p{\dimexpr(.2225\linewidth-2\tabcolsep)}}{aurous} &
  \multicolumn{2}{p{\dimexpr(.5185\linewidth-2\tabcolsep)}}{} &
  \\
D &
  \multicolumn{2}{p{\dimexpr(.2225\linewidth-2\tabcolsep)}}{Pseudomonas aeruginosa } &
  \multicolumn{2}{p{\dimexpr(.5185\linewidth-2\tabcolsep)}}{Should be absent/ml} &
  Absent /ml\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Yield statement of finished products} }
\label{tw-a9ba54031572}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.1682\linewidth-2\tabcolsep}p{\dimexpr.4918\linewidth-2\tabcolsep}p{\dimexpr.34\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}S.No & Stage & Result\\
\tblmidrule 
1 &
  Filling and sealing &
  24204Nos\\
2 &
  Percentage of yield &
  96.82\%\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}
indirectly, partially or fully, should be validated.

A process should also be validated to meet regulatory requirements. The Regulatory bodies, such as the FDA, shall need process validation. The USFDA Quality System Regulation requires manufacturers to perform validation when the process is not completely verified by an appropriate inspection or test \unskip~\citep{1398192:24806896,1398192:24806891}.  A properly and completely validated, controlled process results in little scrap or reprocessing, leads an increased output. Consistent compliance to specifications also results in fewer complaints and recalls. Whenever needed, the validation document contains the data to assist any improvements in a process or in the design of the next generation of the process \unskip~\citep{1398192:24806894}.
    
\section{Materials and Methods}
Following raw materials are used in the manufacturing of sucralfate oral suspension. All the raw materials were tested in the quality control department and individual certificate of analysis is generated and it assures that all the materials will complies with specifications. The sucralfate oral suspension contains Sucralfate (API), Oxetacaine(API), Sodium Benzoate, Butyl hydroxyl anisol, Propylene glycol, Glycerin, Sorbitol solution 70\%, Activated dimethicon, Xanthum gum, Flavored mint, Colloidal silicon, Sucralose, Sorbitol solution and Purified water.

Following critical process variables were identified capacity of the mixing tank, mixing time, mixing speed, process time, pH of purified water, conductivity of purified water.

\textbf{Manufacturing process}

All the APIs along with the excipients were mixed in the SS manufacturing tank and after mixing the suspension is transferred into \#60 mesh in order to filter the suspension. After filtration decartoning, washing and drying of empty PET bottles were done and the filling and sealing operation were performed. The steps in the manufacturing are shown in Figure~\ref{f-bb07d7933abd} and packing is shown in Figure~\ref{f-3ac2dfe0228a}.

\textbf{Details of equipment's used in the manufacturing of sucralfate oral suspension }

Following are the equipment's used in the manufacturing of sucralfate oral suspension Manufacturing Tank (Capacity:8000 L, 4000 L), Bulk Holding Tank(Capacity:5000 L), Transfer pump(2000 LPH), Transfer Line, Homogenizer (in Line) 2000 LPH, SS Container(50 L), Bottle Washing Machine(7200BPH), Filling \& Sealing Machine(7200BPH), Sticker Labelling M/C(7200 BPH).

\textbf{Details of sampling plan in process validation of sucralfate oral suspension}

The process of mixing shall be evaluated for homogeneity of the solution through the sampling of mixed materials from 5 locations (T1, T2 from Top Layer \& M1, M2 from Middle layer \& B from Bottom Layer) after 10 minutes, 15 minutes and after 20 minutes of mixing. Sample shall be collected from different locations using suitable sampler to conduct Description, pH, identification, Weight/ml \& Assay of the Bulk Solution. The process of filtration shall be evaluated by taking samples from 10, 15- and 20-min intervals and after filling the filled bottles were collected at initial middle and final stage of the filling and sealing process.
    
\section{Results and Discussion}
The samples were collected and tested and all the equipment's used in the manufacturing of sucralfate oral suspension were qualified. 

The critical process variables were tested for the manufacturing of sucralfate oral suspension and results were shown in theTable~\ref{tw-e8d50f9f0860}. All the process parameters were performed and the results were shown in the Table~\ref{tw-28eaf67f4e82}. Sampling locations depicted in Table~\ref{tw-efbcf56a0c5a}. Environmental monitoring of manufacturing area was done and the results were shown in the Table~\ref{tw-845b3f25ebe2}. Yield statement of bulk suspension is given in Table~\ref{tw-3ba1736b9f6c}. The bottle washing details were given in Table~\ref{tw-7522e6751dc7}. Empty bottle physical appearance test is done and it is free from fibred and coloured particles. The parameters at the filling and sealing operation were determined and results are shown in Table~\ref{tw-2777da23a85e}. Process veritable results were shown in Table~\ref{tw-bb8dc171e6e2}. In-process product analysis during filling and sealing operation were determined and results were shown in Table~\ref{tw-52eec559b856}. Environmental monitoring of filling and sealing area is monitored and results were given inTable~\ref{tw-625373cce483}. Finished product analysis of sucralfate oral suspension results were shown in Table~\ref{tw-c0332f7eda43}. Yield statement for finished product is shown in Table~\ref{tw-a9ba54031572}.
    
\section{Conclusions}
The equipment used in the manufacturing of the sucralfate oral suspension IP 200ml were checked for their Installation, Operation and Performance Qualification and verified. Key variables in the preparation of sucralfate oral suspension were selected and all the critical process variables are were found within the limits.The process condition at each unit operation was established. The process parameters in the preparation of sucralfate oral suspension were meeting its predetermined specifications. Hence, the process validation of sucralfate oral suspension was performed and the process meets its predetermined specifications and hence the product is maintaining the good quality from the first step to the final step of validation.

\textbf{Conflict of Interest}

The authors declare that they have no conflict of interest for this study.

\textbf{Funding Support}

The authors declare that they have no funding support for this study. 
    

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\end{document}
