by 1.0 OBJECTIVE
To lay down a procedure to conduct annual product quality review for manufactured in calendar year.
2.0 SCOPE
This SOP is applicable products manufactured.
3.0 RESPONSIBILITY
Officer/Executive: QA shall be responsible for collection of relevant data and information required for preparing APQR.
Head – Quality Assurance/Designee shall be responsible for assuring that all provisions of this SOP are fulfilled and for approval of annual product review.
4.0 ACCOUNTABILITY
Concerned Department head and QA Head shall be accountable for implementation of this SOP.
5.0 PROCEDURE:
All the batches of a product manufactured a financial rear shall be considered while preparing the APRQ for Example: the batches manufactured between the months of April and march on next year i.e. a product with a cut-off date of march 31 for the APQR will require all the batches released or rejected during 12 months preceding march 31 will be included in the APQR for that year.
The APQRs for all the products for one financial year shall be prepared, complied and approved within the time period of 03 months after the closing of the financial year on the basis of the inferences of APQR, CAPA shall be initiated within 06 month after the end of the financial year, if required.
Officer/Executive QA for preparing the APQR 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 department.
Each set of data shall be tabulated and graphed in such a fashion as to easily exhibit (display) results, deviations and quality trends etc.
QA personnel shall allocate a fourteen-digit number to the APQR form and sign. With date. The number shall be in APQR/YY-ZZZ, where
First four character ‘APQR’ are abbreviation of annual product quality review.
The second character shall be a ‘/’ (Slash).
Third and two characters ‘YY’ represents years e.g. 19 for 2019.
The next characters shall be a‘-’ (dash).
The next three character ‘ZZZ’ represents serial number of APQR i.e. 001, 002, 003 etc.
The first APQR of the year 2019 shall be numbered as APQR/19-001
A new series of APQR number shall start at the beginning of new calendar year.
The data shall be collected from the records and recorded and format annual product quality review against the relevant points.
5.1 Product Description: Products detailed description i.e. product name, generic name, label claim, strength, packing type, M.F. No., batch Size , shell life, Indications and any other specific information related to product shall be included.
5.2 Time Period covered: This shall include all batches manufactured or disposition (released or rejected) during a financial year i.e. from April to march next year.
5.3 Manufacturing and testing procedure followed for the product.
5.3.1 Master Formula No.(Manufacturing & Packaging): A record of master formula No. used for batches included in APQR. If there is any change in master formula No. then reason for change along with change control reference no. shall be mentioned.
5.3.2 Specification / STP (In-Process, Finished product & Packaging component): All the specification / STPs reference number shall be given for reviewed batches. If there is any change in specification / STP the reason for changes along with change control reference no. shal be mentioned in APQR.
5.4 Finished Product Results: Summary of finished product results of all the batches considered while preparing the APQR shall be represented. The trend of the results shall be prepared and presented suitably. Conclusion and recommendations, if any shall be documented in the APQR.
Softgel Capsules Finished Product: Average fill weight, Disintegration time , Assay, yield or any other relevant test shall be considered but may not be restricted to these parameters only.
5.5 In-Process Results: Summaryof in-process results of all the batches considered while preparing the APQR shall be represented. The trend of the results shall be prepared and presented suitably. Conclusion and recommendations, if any, shall be documented in the APQR.
Capsules in-process: LOD, Average fill weight, disintegration, Yield & Assay but may not restricted to these parameters only.
5.6 Environmental Conditions during manufacturing operation: The data of environmental conditions during the manufactured of all batches shall be reviewed and recorded in the APQR.
5.7 Critical Equipment performance: The critical equipment used during the manufacturing of product shall be identified and overall performance of these equipment shall be evaluated by reviewing the breakdown and preventive maintenance records. The observations shall be recorded in the APQR.
5.8 Process Deviation / change controls: All product or process deviations, investigation conducted for deviations or change control for in procedure or product parameters shall be recorded. Any corrective actions derived from these changes and effect of these changes on product quality shall be summarized. The observations shall be recorded in the APQR.
5.9 Out of Specification and out of trend: All the cases of out of specification for particular product (API, In-Process, Finished Product & Packing Component) filled by quality control during respective financial year for particular product shall be mentioned (if any) . Out of trend results. If any observed during stability studies shall also be recorded in the APQR.
5.10 Non-Conformance Report: All details of non-conformance report generated in the respective financial year for particular product shall be mentioned (if Any) in the annual product quality review.
5.11 Product Complaints: Summary of all product complaints shall be summarized and any trends or problematic batches shall be additionally reviewed.
5.12 Return goods or recalled products: Details of any returned goods or recalled batches shall be listed in the APQR.
5.13 Yield Reconciliation: The yield of batches of the product shall be reconciled and variations along the trend shall be observed and reasons elucidated in APQR.
5.14 Adverse drug reaction: Data on adverse drug reaction, if any, shall be summarized in APQR.
5.15 Active pharmaceutical ingredient data: The data of API shall be collected and recorded appropriately. The data shall include name of ingredients, manufacturer / supplier name and address, number of consignments received, number of consignment approved, number of consignment rejected with cause of rejection (if any).
5.16 Raw Materials (API) Manufacturer / Supplier performance review: The review of manufacturer or supplier who is supplying the active ingredients shall be taken based on the approval and rejection record of API received.
5.17 Conclusion and recommendations: The conclusion regarding the process consistency with respect to yield, quality, stability and recommendations to continue the manufacture as per the process being followed.
6.0 TRAINING
Trainer : Head – Quality Assurance
Trainees : Staff of all the departments
7.0 DISTRIBUTION
Master Copy : Quality Assurance
Controlled Copy : Quality Assurance
8.0 ATTACHMENT
| Sr. No. | Annexure No. | Title | Format No. |
| 1 | NA | NA | NA |
9.0 REFERENCES
In-house
10.0 ABBREVIATION
| Abbreviation | Extended Form |
| EG | Engineering |
| SOP | Standard Operating Procedure |
| QA | Quality Assurance |
| WH | Warehouse |
| NA | Not Applicable |
| MB | Microbiology |
11.0 REVISION HISTORY OF CHANGE
| Sr. No. | Date | Revision Details | Revision No. |
| 1 | NA | New SOP | 00 |
