SOP Title: Release of finished products
- Objective:
To lay down procedure for release of finished products for sale or distribution.
- Scope:
This procedure is applicable for release of finished products for sale or distribution of all formulations manufactured at the site.
- Responsibility:
Production department: To complete and review BMR, BPR, attached respective documents and follow the procedure.
QA department: To review BMR, BPR, analytical test report, inspection of finally packed batch, daily production report and release of batch for sale or distribution as per procedure.
QC department: Analysis of bulk/semi finished and finished product and submit the report to QA department as per procedure.
- Accountability:
Head QA Production/QC department
- Procedure:
- Definitions:
- QA Associate: Executive, officer of quality assurance department or the person trained to perform job as per this SOP.
- Production Associate: Executive, officer of production department or the person trained to perform job as per this SOP.
- QC Associate: Executive officer of quality control department or the person trained to perform as per this SOP.
- Finished product: A finished dosage form, for example a tablet, capsule or solution that contains an active pharmaceutical ingredient, generally but not necessarily, in association with inactive ingredients in a final marketed pack.
- Procedure:
| 5.2.1 | The finished goods which are finally packed and supported with documents BMR/BPR, batch analytical record (BAR) of the particular batch shall be submitted to Quality Assurance department as soon as completed. |
|
||||||||||||
| 5.2.2 | Before sending BMR, BPR to QA department production head/designee shall check and review the batch documents as per Annexure. | |||||||||||||
| 5.2.3 | Before sending Analytical Test Report to QA department, it shall be checked and reviewed as per specification to ensure the results are within specifications and satisfactory. | |||||||||||||
| 5.2.4
|
After receiving the particular BMR, BPR, analytical test report etc from production and QC departments, all the batch documents shall be comprehensively reviewed. | |||||||||||||
| 5.2.5 | Final or terminal inspection of finished products shall be carried out as per procedure given in step 5.5 | |||||||||||||
| 5.3 | Review of Batch Manufacturing Record (BMR) and Batch Packing Record (BPR) | |||||||||||||
| Following points shall be checked for BMR and BPR | ||||||||||||||
| 5.3.1 | The product name with dosage, batch number, batch size, date of manufacture and expiry date mentioned on the BMR & BPR is correct. | |||||||||||||
| 5.3.2 | The Raw material/ Packing materials used for the manufacturing / Packing are in the list of approved vendors. The raw materials and packing materials used are tested and approved by Quality control department. | |||||||||||||
| 5.3.3 | Before dispensing, line clearance of dispensing booth is carried out. | |||||||||||||
| 5.3.4 | Active Pharmaceutical Ingredients and excipients are issued and checked by authorized personnel as per the BMR & BPR and if there is any potency based calculation it is counter checked by the QA manager. | |||||||||||||
| 5.3.5 | Before initiating manufacturing, line clearance is taken for area and equipment from QA wherever necessary. The environmental conditions are maintained during the manufacturing process and packing (i.e. RH, Temperature). | |||||||||||||
| 5.3.6 | Manufacturing operations are followed as per the instructions given in master formulation record. The manufacturing operations are counter checked by competent technical manufacturing staff. (Wherever applicable). | |||||||||||||
| 5.3.7 | The critical process parameters are well within the limits and critical in-process controls are done as per the frequency mentioned in the BMR & BPR and are well within the limits and the in-process quality control analytical reports are enclosed Batch card. | |||||||||||||
| 5.3.8 | If there is any process deviation, it is recorded and it is investigated and approved by Quality Assurance department. | |||||||||||||
| 5.3.9 | The correct packing components are used as per packing material requisition slip which is authorized by the department head. | |||||||||||||
| 5.3.10 | The line clearance is carried out during packing operation as per the BPR. | |||||||||||||
| 5.3.11 | Over printing/coding details are correct and appropriate as per the BPR. | |||||||||||||
| 5.3.12 | Blister packing in-process checks are performed as per the frequency mentioned in the BPR and counter checked by competent technical staff. | |||||||||||||
| 5.3.13 | The reconciliation records of packing materials are well within the limits. | |||||||||||||
| 5.3.14 | The specimen of coded /printed aluminium foil/ blisters, cartons or product label and shipper label attached to BPR which are duly signed by the production personnel and counter checked by Quality Assurance personnel. | |||||||||||||
| 5.3.15 | The batch is manufactured and packed under the supervision of a competent technical staff. | |||||||||||||
| 5.3.16 | All these above points shall be ensured and filled as per Annexure. | |||||||||||||
| 5.4 | Review Batch Analytical Record (BAR) | |||||||||||||
| Following points shall be checked for BAR | ||||||||||||||
| 5.4.1 | Drug products at all stages are analysed as per the established specifications and are well within the specified limits and analysis shall be carried out by certified analyst. | |||||||||||||
| 5.4.2 | The raw data/ protocols/ HPLC & GC chromatograms, UV/ IR spectrum are enclosed with the analytical report and counter checked by competent technical staff. | |||||||||||||
| 5.4.3 | Working standard is standardized and is within validity period. | |||||||||||||
| 5.4.4 | The certificate of analysis is prepared by analyst and checked by Quality Control head. | |||||||||||||
| 5.4.5 | The microbiological analysis of finished products (Wherever applicable) shall be carried out as per the established specifications and the results are well within the limits. | |||||||||||||
| 5.5 | Final or terminal inspection of finished products | |||||||||||||
| 5.5.1 | When the finished products are finally packed, the daily production report shall be generated in triplicate which is forwarded to Quality Assurance department. | |||||||||||||
| 5.5.2 | On receipt of the daily production report, In-process Quality Assurance (IPQA) personnel or QA designee shall contact the concern chemist of production department & check the packed products | |||||||||||||
| 5.5.3 | It shall be ensured that the batch manufacturing record is complete and signed before inspecting the packed finished products | |||||||||||||
| 5.5.4 | The finished product shall be transferred to Finished Goods Store only after release for sale or distribution | |||||||||||||
| 5.5.5 | Quantity specified on the daily production report shall be checked and verified physically same as mentioned on the daily production report.
Following method shall be followed for inspection of finished products- 10 % of the batch size (total number of boxes/shippers) with defined number and three additional boxes/shippers shall be inspected for final inspection. The boxes/shipper to be inspected shall be identified and 100 percent units shall be inspected from these selected boxes. Example: If there the total lot or batch size is 90 shipper/boxes, then the total number of shipper to be inspected shall be 9 + 3 (10 % + 3 additional boxes).To ensure uniform sampling of batch every 9th number box shall be identified for inspection along with additional boxes. |
|||||||||||||
| 5.5.6 | The selected boxes/shippers shall be opened and checked for the following:
· Product name · Batch no. · Date of manufacturing · Date of expiry · MRP, if any · Special marking, if any · Quantity of units per box/shipper · Unit or blister/strip per carton/units. · Physical checks · Any discrepancy/defects Subsequently the cartons shall be replaced in their respective shipper after inspection. If any discrepancy is not found, the shipper shall be immediately packed. |
|||||||||||||
| 5.5.7 | If any discrepancy is found, it shall be noted down, informed to production head, QA head and necessary correction shall be taken. | |||||||||||||
| 5.5.8 | Finally all the packed boxes/shipper shall be checked for outer label, adhesive tape, physical status, any defects and strapping wherever required. | |||||||||||||
| 5.5.9 | If the checked finished goods comply with the stated requirement of the batch manufacturing record and daily production report, A final inspection report of finished product shall be prepared as per Annexure and submitted to QA head/delegate. | |||||||||||||
| 5.6 | Release of finished products | |||||||||||||
| 5.6.1 | The inspected finished goods shall be kept in Finished Goods Quarantine and labelled as ‘Quarantine’ after final inspection till QA release. | |||||||||||||
| 5.6.2 | When BMR, BPR, batch analytical records, Daily production report and final inspection of finished pack product report are found satisfactory, then the finished product shall be released by Authorized person (Head QA or his authorized delegate) for distribution/sale and the respective documents shall be signed. | |||||||||||||
| 5.6.3 | Once finished product is released for sale/distribution, the status label on the CBs/shippers shall be changed as “QA RELEASE” and the goods shall be transferred to Finished Goods Store with complete batch record. | |||||||||||||
| 5.6.4 | The released finished product entry shall be made in Annexure ‘Finished Product Release Register’ | |||||||||||||
| 5.6.5 | The release shall be conveyed to Production head or his authorized designee and commercial store in-charge through preparing a report in “Daily Production Report” from specified booklet filling all details under “QC detail “column.
Copies of the report shall be kept as following:
|
|||||||||||||
- Abbreviation:
| Abbreviation: | Expansion |
| BMR | Batch Manufacturing Records |
| BPR | Batch Packing Records |
| SOP | Standard Operating Procedure |
| CB | Corrugated Box |
| i.e. | Id est (that is) |
| RH | Relative Humidity |
*Note – Ready to use SOP available in “DOWNLOAD” Section.