To clearly lay down procedure for release of finished product.
This is applicable to release finished product of all formulation.
3.1 Doing : Tech. Asst./Executive /Manager
3.2 Checking : Executive /Asst. Manager /Manager
Head of the Department
5.1 On receipt of finished product sample along with intimation slip from Quality Assurance department, QC will give QC Report no. as per following logic.
5.1.1 Product Manufacture at Plant.
Where X Indicates Type of formulation
e.g. = T for Tablet
C for Capsule
P for Parenteral product
Z = indicates Sr. No. of analysis carried out for different specification of same batch No Staring with 1.
W = Indicates location code
Y = indicates B.No. of the respective product.
A = indicates lot no of batch if it is given.
5.2 Enter the details respectively in register maintained for Tablet, Capsule, Parenteral and Contract Mfg.
5.3 After completion of entry, put the sample in to “UNDER TEST SAMPLE” tray.
5.4 Quality Control Section Incharge/ Executive shall distribute the sample along with intimation slip controlled testing data sheet and ‘Prior to the chemical section , instrument section & microbiology section for respective analysis. The details of the protocol distribution to each section is to be maintained in protocol distribution list as per SOP.
5.5 Chemist shall analyse the sample after referring respective specification and method of analysis, record the results in data sheet and record result in SAP system.
5.6 If any result is found out of specification, follow SOP for OOS.
5.7 On completion of testing, give report to QC Section Incharge/ Executive for checking
5.8 Quality Control Section Incharge / Executive shall check the results of chemical, instrument and microbiological testing. Sign the report on finding it satisfactory and Section Incharge/ Executive give user decision.
5.9 Sign the report on finding it satisfactory. QC Section Incharge / Executive shall give User Decision after checking all results.
5.10 Quality Control Section Incharge / Executive enter the result into respective entry register as per annexure.
5.11 After completion of entry, Quality Control Section Incharge/Executive will fill the details in the ‘Prior to packing release slip in triplicate and release the product for packing.
5.12 QC Section Incharge/Executive will send yellow and green copy to production Dept. and attach the third white copy with testing report.
5.13 In absence of responsible person, Technical Assistant shall convey the results to production department and send “ Prior to packaging release slip” to production dept. duly signed by analyst.
5.14 After completion of testing destroy the sample as per SOP.
5.15 Put report in to tray ‘report for computer entry’. QC Section Incharge / Executive will check & sign the computer generated COA and send total QC testing report along with COA to QA department
5.16 For export product follow instruction from the respective section or PPC section attach respective specification in SAP system, allot the Q.C A.R No to sample and attach the intimation which is received from packing section make entry in Export register Annexure & keep the sample in to “ UNDER TEST SAMPLE” tray.
5.17 Q.C. Section Incharge/ Executive distributes the sample along with “Export Plan Slip” if received and controlled testing data sheet (for Export).
5.18 Review the export data sheet on any country specification for its specification & MOA. If it is found similar as like in domestic then on basis of analysis carried out earlier, mention the same Q.C A.R. No. against each test in export data sheet as reference and no need to perform analysis.
5.19 In Export data sheet if test method is different, then analyst shall carry out analysis of that test as per respective method and report it in the data sheet,
5.20 Follow step No. 5.5 to 5.9.
5.21 After completion of testing QC Section Incharge / Executive will Send white copy of “Export Plan Slip ” with Status of complies or does not comply to Pkg. department and attached another pink copy with report & follow step No 5.16
5.22 After completion of testing destroy the sample as per SOP.
6.1 Q.C=Quality control
6.2 Q.A= Quality Assurance
6.3 S.O.P..= Standard Operating Procedure
6.4 A.R. Number = Analytical Report Number
6.5 MOA = Method of analysis
6.6 SAP = System Application procedure
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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