SOP on Product Quality Review
Objective : To lay down a procedure of Product Quality Review for the products manufactured in the respective financial year.
Scope : This Standard Operating Procedure is applicable for all products manufactured in formulation plants of for European Union, W.H.O, Geneva or for any specific customer requirement.
Responsibility :
Officer / Executive – QA shall be responsible for collection of relevant data and information required for preparing Product Quality Review.
Head-Quality Assurance / designee shall be responsible for assuring that all provisions of this SOP are fulfilled and for the approval of Product Quality Review.
Abbreviations and Definitions
Product Quality Review (PQR).: The product Quality Review is an effective quality Improvement tool to enhance the consistency of the process and overall quality of the product, capturing a trends and will help determining the need for revalidation.
Retrospective Validation : Historic data taken from the records of the previous production batches used to provide documented evidence that the process has been in state of control prior to the request for evidence.
Procedure :
All the batches of a product manufactured in a financial year shall be considered while preparing the PQR. For example batches manufactured between the months of April and March of next year i.e. a product with a cut-off date of March 31 for the PQR will require all the batches released or rejected during 12 months preceding March 31 will be included in the PQR for that year.
The PQRs for all the products for one financial year shall be prepared, compiled and approved within the time period of 03 months after the closing of the financial year and on the basis of the inferences of PQR, CAPA shall be initiated within 06 month after the end of the financial year, if required and as per SOP titled “Quality Management Review”.
Officer / Executive, QA preparing the PQR shall collect, summarize and review the related data from BMRs (process parameters), process deviations, change controls, NCRs, market complaints, returned goods, recalled products, etc. along with the other analytical data obtained from other departments.
Each set of data shall be tabulated and graphed in such a fashion as to easily exhibit results, deviations and trends, etc.
The data shall be collected from the records and recorded in the format Product Quality Review against the relevant points.
Objective: Product Quality Review is regular periodic or rolling quality review of a product which is conducted with the objective of verifying the consistency of existing process, the appropriateness of current specifications to highlight any trends and to identify product and process improvements.
Abbreviations & Definitions: Describe the meaning or explanation of terms which are not comman or having any specific meaning & expansion of abbreviations.
Reference of PQR: Bibliography shall be made enlisting the documents/guidelines referred while preparing the PQR for a product.
Product Description: Product’s detailed description i.e. product name, product code, generic name, label claim, pack style, batch sizes available, market and shelf life.
PQR review Period: This shall include all batches manufactured or disposition (released or rejected) during a financial year i.e. from April to March next year.
Raw material (API & Excipients)/ Packaging Material with Vendor Details: A review of staring materials and product contact primary packaging materials used for the product, especially those from new source. The data shall include name and address of manufacturer/supplier with respect to the name of ingredients and packaging components, number of consignments received, number of consignments approved, number of consignments rejected with cause of rejection (if any) in a year and the approval status of the vendor.
Critical in process and finished product test results: Summary of all in-process results and finished product results of all the batches considered while preparing the PQR shall be represented. The trend of the results shall be prepared and presented suitably. Conclusion and recommendations (if any), shall be documented as annexure-2 of the PQR.
Tablets in-process: LOD, assay, yield, etc.
Capsules (hard gelatin and soft gelatin) in-process: LOD, water content, assay, etc.
Liquid Oral/Ointment/Gel in-process: pH, weight per ml, viscosity, assay, etc.
Tablets Finished Product: average weight of tablets, disintegration time, assay, yield or any other relevant test shall be considered.
Capsules (hard gelatin and soft gelatin) Finished Product: average weight of capsules, disintegration time, assay, yield or any other relevant test shall be considered..
Liquid Oral/Ointment/Gel Finished Product: pH, weight per ml, viscosity, assay, yield or any other relevant test shall be considered.
Batch Failure and Investigation: Summary of all the batches that failed to meet established specification(s) and their investigation shall be recorded.
Deviations and/or Non–conformances and investigations: Summary of all the deviations and / or non conformance and their investigations and CAPA taken and their outcomes / effectiveness shall be recorded.
Changes in process and analytical methods: Summary of the changes, if any, to the process for instance change of mixing time, drying time, compression speed/time, etc. Similarly, the summary of the changes made to the analytical methods, e.g. change of solvent, buffers, pH, etc. shall be recorded.
Status of marketing authorization for variations: Record the marketing authorization variations granted/submitted/refused for the product in the PQR.
Stability results Analysis: Summary of stability study report and results i.e. out of specifications for each conditions (real time/ long term and accelerated studies) shall be recorded.
Returns, complaints, recalls and investigations: The quality related product returns, complaints and recalls and the investigations performed at the time, shall be recorded in the PQR.
Adequacy of previous process or equipment corrective action: Summary of all corrective actions w.r.t the process and equipment shall be recorded.
Review of Post marketing commitments: State any post marketing commitments and the status of these commitments.
Review of qualification status of relevant equipment’s and utilities: The qualification status of relevant critical equipment’s and utility system shall be stated.
Review of technical agreements: To review the technical agreements to ensure that they are up to date.
Revalidation: If, required, revalidation shall be performed and documented in the PQR
Conclusion: The conclusion and recommendations (if any) drawn from the PQR shall be recorded.
Wherever applicable, related statistical analysis shall be performed. Record the observations and inferences on the analysis of data in the format given in Observations and Inference.
All pages of the PQR shall have the logo of the company, printed at the top left corner.
The brand name, if any, and generic name and label claim of the product.
All pages shall be compiled and numbered properly.
A cover page shall be prepared giving the Product name, year of review, along with location of manufacture of product.