- Objective :To lay down the procedure for release of finished products.
- Scope:This SOP covers the responsibility and procedure for the approval and release of Finished Products for distribution.
- Production, Finished Good Store, QC and QA personnel shall be responsible to follow the procedure mention in this SOP.
- Head of respective department and QA Head or his designee is responsible for compliance of this SOP.
- QA Head shall be accountable for implementation of this SOP.
- Abbreviations and Definitions
|SOPs||:||Standard Operating Procedures|
|BMR||:||Batch Manufacturing Record|
|PTN||:||Product Transfer Note|
- Ensure that the Batch Manufacturing Record has been reviewed and audited by Production in all aspects. The reconciliation of the materials and product yield are carried out at the respective stages of the operation.
- Ensure that Production Manager has reviewed the completed BMR before it is submitted to Quality Assurance for final audit and release of the Finished Product for distribution along with Product Transfer Note.
- QA personnel shall review & verify the following points before preparing the release order:
- Review the Batch Manufacturing Record as per respective SOP.
- Verify that the product has been approved by Quality control with respect to its testing as per the Product release specification. Ensure that the Certificate of Analysis (COA) and Record of Analysis have been signed and the entry has been made to Finished Product sample register.
- Attach the COA along with the BMR; make the signatures & date at specified places.
- Verify the Quantity being released from quantity transferred to Finished Goods Store on ‘Product Transfer Note’ and attached with the BMR.
- After verification QA personnel shall prepare a ‘RELEASE ORDER’ in duplicate, giving the details of Product Name, Batch details, Analytical Reference Number, Break-up of packed quantity and total quantity released for sale on basis of the Batch manufacturing.
- A serial no. shall allocate to the release order and signature with date shall be done by QA personnel.
- Signed Release order along with the Batch Manufacturing Records shall submit to the Head QA or his designee for final release of the Finished Product.
- Head QA shall final review the BMR & put his sign with date on BMR and release order.
- Head QA shall forward BMR & release order to QA personnel.
- QA personnel shall send the Second copy of the ‘RELEASE ORDER’ to the Finished Goods Store, so that the dispatch of Finished Products shall be planned.
- The First copy of the release order shall be attached with batch manufacturing record and QA personnel shall finally archive the BMR in documentation cell.
- In case a batch has to be released partially, the BMR shall be completed up to that stage & reviewed by Production and QA.
- After review of BMRs, if QA personnel shall found all the specification of product are meeting with finished product specification till stage then ‘PARTIAL RELEASE NOTE’ shall be prepared for partial quantity of batch by QA personnel and shall approved by Head QA or his designee.
- In case of other than bifurcated batch, partial status shall be mentioned in BMR, while in case of bifurcated batch, the final release status shall be mentioned in BMR.
- If all bifurcated quantity is being released on the same date, then ‘RELEASE ORDER’ shall be prepared only, no need to prepare ‘PARTIAL RELEASE NOTE’.
- Put the remark on ‘Remark’ column of Finished Product release record by mentioning country in case of bifurcated batch and export batch.
- For the tests, which take longer time for completion e.g. Sterility test, Microbial limit test and Suspension stability analysis, to save time of transportation, a ‘PROVISIONAL RELEASE’ shall be given for dispatch of the products up to Depots / Distributors.
- Dispatched products through provisional release shall meet finished product specification except mentioned tests in point no. 6.15 and further dispatch to market, the product shall be upon confirmation of product final release.
- Final release for further sale shall be given only after completion of the above-referred tests described by preparing ‘RELEASE ORDER’ and written informing Finished Goods Store personnel for final release.
- Final release order shall attach with Batch manufacturing Records and handover to Documentation Officer/Executive.
- Records the release of finished product in Logbook for batch release of finished products.
MASTER FORMULA OF COLD TABLETS (drugsformulations.com)
- Forms and Records
- Release Order – Annexure-I
- Partial Release Note – Annexure-II
- Provisional Release Note – Annexure-III
- Logbook for batch release of finished products -Annexure-IV
- Master copy – Quality Assurance
- Controlled copies – Quality Assurance, Production, Quality Control, Store.
Reason for Revision
MASTER FORMULA OF SALBUTAMOL TABLET (drugsformulations.com)
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube