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A Product Which Has Completed All Stages of Manufacture, Including Final Packaging

This standard operating procedure outlines the process for releasing drug substance, semi-finished goods, and finished goods for clinical trials, distribution, sale, and animal toxicity studies. It describes the responsibilities of various departments in reviewing batch records, testing samples, reviewing analytical results, approving batch manufacturing records, performing usage decisions in SAP, and releasing batches. Key steps include manufacturing and quality control departments reviewing and approving batch records, quality control testing and approving samples, quality assurance approving batch records and performing usage decisions, and quality assurance or manufacturing affixing approved labels to released containers.

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om shankar Jha
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844 views

A Product Which Has Completed All Stages of Manufacture, Including Final Packaging

This standard operating procedure outlines the process for releasing drug substance, semi-finished goods, and finished goods for clinical trials, distribution, sale, and animal toxicity studies. It describes the responsibilities of various departments in reviewing batch records, testing samples, reviewing analytical results, approving batch manufacturing records, performing usage decisions in SAP, and releasing batches. Key steps include manufacturing and quality control departments reviewing and approving batch records, quality control testing and approving samples, quality assurance approving batch records and performing usage decisions, and quality assurance or manufacturing affixing approved labels to released containers.

Uploaded by

om shankar Jha
Copyright
© © All Rights Reserved
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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1.

0 OBJECTIVE:
To provide a procedure for release of Drug Substance (API), SFG (Drug Product) and FG (Drug
Product) for Clinical Trails/Distribution/sale and ATOX.
2.0 SCOPE:
This SOP is applicable for all Drug Substance (API), SFG (Drug Product) and FG (Drug Product)
3.0 RESPONSIBILITY:
4.1. USER/MANUFACTURING DEPARTMENT HEAD/DESIGNEE :
4.1.1 Execution of batch review checklist.
4.1.2 Review of Batch Manufacturing Record.
4.2. QUALITY CONTROL DEPARTMENT HEAD/DESIGNEE:
4.2.1 Shall be responsible for testing, review and reporting of analytical results and updating
in SAP.
4.2.2 Shall be responsible for printing of COA and Approved/Rejected Label.
4.3. QAD HEAD /DESIGNEE:
4.3.1 Shall be responsible for compliance of this SOP.
4.3.2 Shall be responsible for review of relevant record and release of Drug Substance or FG
(Drug Product).
4.3.3 Shall be responsible for review and approval of BMR.
4.4 QAD Head is accountable for implementation and compliance to this SOP.
4.0 ABBREVIATIONS:
BMR Batch Manufacturing Record PRC Product Release Certificate
BPR Batch Packaging Record SOP Standard Operating Procedure
COA Certificate of Analysis STP Standard Test Procedure
Finished Goods(Drug Product) QCD Quality Control Department
QAD Quality Assurance Department BRC Batch Release Certificate
DS Drug Substance DP Drug Product
QCD Quality Control Department UM User Manual
UD Usage Decision SFG Semi-Finished Goods
System Application and product
SAP ATOX Animal Toxicity.
in Data Processing
5.0 DEFINITIONS / TERMS:
6.1 ACTIVE PHARMACEUTICAL INGREDIENT (API)/DRUG SUBSTANCE (DS):-
A substance used in a Finished pharmaceutical product, intended to furnish pharmacological
activity or to otherwise have direct effect in the diagnosis, cure, mitigation, treatment or
prevention of disease, or to have direct effect in restoring, correcting or modifying physiological
functions in human beings.
6.2 SEMI-FINISHED GOODS (DRUG PRODUCT):
- Product which has undergone all stages of manufacturing and is waiting for packing in its final
container.
6.3 FINISHED PRODUCT (DRUG PRODUCT):-

A product which has completed all stages of manufacture, including final packaging.
6.0 HEALTH, SAFETY AND ENVIRONMENT PROTECTION:

7.1 NIL
7.0 PROCEDURE:
8.1 On completion of last step of manufacturing process the Manufacturing personal shall perform the
sampling activity in presence of QAD and QCD personal. And perform usage consumption
transaction in SAP.
8.2 Manufacturing department Head or designee shall review the BMR/BPR and execute batch
review checklist “Format -I” and submit to QAD for final review and approval.
8.3 After receipt of the completed batch records (BMR/BPR) from Manufacturing, QAD Head or
designee shall review BMR/BPR and executed filled batch review checklist “Format -I”. The
checklist shall include the following as applicable but not limited to:
8.3.1 DOCUMENTATION:
 The documents are free of obvious errors and complete in all respects.
 Line clearance activities are carried out at all stages.
 Any significant or unusual discrepancy / deviation observed during
manufacturing, analysis and reconciliation of the product (DS/FG) at various
stages are recorded.
 All the relevant annexures / Formats are attached to the BMR / BPR.
 Reconciliation of batch yield is done at all applicable stages and the yield is
within the specified limit as applicable.
 All the relevant chromatograms and analytical data Sheet/Test Request Forms
are attached.
 OOS / deviations, if any, is recorded, investigated and disposition action is
completed. CAPA if any, shall be initiated and closed with the proposed
timelines.
 Other QMS if any, are closed before batch release.
 Completed Raw Data sheet shall be checked by QAD personnel.
8.3.2 SAMPLE COLLECTION AND OTHER PRE-REQUISITES:
 Stability samples are collected and submitted, as applicable.
 Control samples are collected, checked for correctness of quantity and batch
details.
 The batch conforms to Technical Agreement of Supply, if applicable.
 Details of drug license is verified for the respective country and / or customer, as
applicable.

8.4 BATCH DISPOSITION:


8.4.1 QCD shall perform the analysis of samples received and record the details of analysis in
Raw Data sheets as applicable.
8.4.2 After the receipt of completed Raw Data sheet, QAD Head/designee shall ensure the
following but not limited to:
8.4.2.1 Correctness and completeness of results as per respective Specification /
STP.
8.4.2.2 Compliance to bracketing standards and system suitability requirements.
8.4.2.3 Compliance to GDP.
8.4.3 QAD Head or designee shall check the results of the batch for applicable tests with
established limits for a product.
8.4.4 QCD shall record the results in SAP as per SOP_________
8.4.5 QCD Head shall review all the results recorded against the Raw Data Sheet using
transaction code QEDS
8.4.6 After QAD final review of BMR, QAD Head/Designee shall Approve the BMR and
performed Usage decision by using transaction code QA32 by selecting the usage
decision icon (refer user manual “TLS-QMUM-003-SAP” ),and enter the sample quantity
taken as control samples or custom sample or Stability sample in the field “To sample
usage”.
8.4.7 Simultaneously QAD Head/Designee shall prepare batch release certificate as per
‘Format-II’ for the product and batch, with the sale order quantity as applicable. This is
available as reference document for batch release in QAD.
8.4.8 In case of batch is to be released on partial testing analysis results of Description
Appearance, pH, Assay and SEC test shall be available.
8.4.9 Manufacturing team shall request for interim release of the batch as format number-
IV .Requisition to be approved by head Quality.
8.4.10 Based on the approved interim batch release requisition QCD shall prepare the interim
release COA.
8.4.11 In the absence of the designated person carrying out SAP transaction or during their
pre-occupation, his/her superior shall release the batch in SAP after verifying the
required documents.
8.4.12 After the Usage decision QCD Head/Designee shall print the COA and Approved
Label / Rejected label as per SOP no. ___________ And handed over to QAD
Head/Designee.
8.4.13 Original PRC and COA shall be attached to the BMR and Raw data sheet respectively.
Attach one original copy of COA with BMR, After confirming the Expiry date on COA.
8.4.14 After batch disposition , QAD shall make necessary entries and archive the BMR/BPR
8.4.15 After receipt of label from QCD, QAD Head / Designee shall affix the Approved label /
Rejected Label whichever applicable on DS container.

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