OBJECTIVE:

• To establish a uniform procedure for release of each batch of finished product only after verification that it has been manufactured, tested, and documented in accordance with GMP and regulatory requirements.
•  To ensure that no product is dispatched without formal written authorization from the Head QA (Authorized Person).

SCOPE:

• This procedure applies to the batch release of all finished pharmaceutical products manufactured at Company.

RESPONSIBILITIES:

Production:

• To ensure completion of all manufacturing and packaging operations as per approved BMR/BPR.
• To perform yield reconciliation and record all in-process controls.
• Submit complete BMR/BPR to QA for review.

Quality Control (QC):

• To test each finished product batch as per approved specifications.
• To prepare and approve the Certificate of Analysis (COA).
• To forward COA and test summary to QA for batch-release evaluation.

 Designee Quality Assurance (QA):

• To review completeness of BMR/BPR and supporting records.
• To verify closure of deviations, change controls, OOS/OOT investigations, and CAPAs.
• To confirm reconciliation, sample collection, and labeling accuracy.
• To ensure compliance with the latest regulatory and internal SOPs.

 Head – Quality Assurance (Authorized Person):

• To perform final review of all batch documents.
• To ensure that all required approvals, investigations, and trending reviews are completed.
• To authorize batch release by signing the Batch Release Authorization.
• To ensure traceability and record retention as per this SOP.

 DEFINATIONS:

• Authorized Person (AP): The Head – Quality Assurance or a formally delegated designee responsible for providing final written authorization of batch release.
•  Batch Manufacturing Record (BMR): A controlled document that records all manufacturing details of a specific batch, including materials, equipment, process parameters, yields, and in-process results. It serves as evidence that the product was manufactured as per the approved master formula and validated process.
•  Batch Packaging Record (BPR): A controlled document that captures all packaging activities of a batch, such as line clearance, coding, reconciliation of printed materials, and in-process checks. It confirms that packaging and labeling were performed per approved instructions and country-specific regulatory requirements.
•  Certificate of Analysis (COA): A formal document issued by the Quality Control department summarizing test parameters, specifications, and actual results for a batch, with a conclusion of “Complies” or “Does Not Comply.”
•  Corrective and Preventive Action (CAPA): A documented process to identify root causes of non-conformities and implement actions to correct existing issues and prevent recurrence. CAPA effectiveness must be verified, and no batch shall be released until all relevant CAPAs are closed.
•  Deviation: Any unplanned departure from approved procedures, specifications, or expected yield observed during manufacturing, testing, or packaging. Deviations are categorized (minor, major, or critical), investigated, and approved by QA prior to product release.
•  Out of Specification (OOS): A result that falls outside approved acceptance criteria during testing. All OOS results must undergo a formal investigation and be resolved before the batch is eligible for release.
•  Out of Trend (OOT): A result that is within specification but shows an unusual pattern compared to historical data or trends. OOT investigations determine assignable causes and help prevent potential future deviations.
•  Change Control (CC): A structured process used to assess, approve, and document changes that may impact product quality, validation, or regulatory commitments. No batch shall be released if an associated change control remains open or unapproved.
•  Reconciliation: A comparison between the theoretical and actual quantities of materials used or produced at various stages of manufacturing or packaging.
•  Quarantine / Released / Rejected Status: Refers to the classification of batch disposition. Quarantine indicates the product is awaiting QA approval, Released indicates approval for sale or use, and Rejected means the batch failed to meet requirements and must be segregated or destroyed as per SOP.
•  Product Quality Review (PQR): An annual review of product quality data covering deviations, complaints, yields, OOS results, and stability trends to verify ongoing process consistency and identify opportunities for continuous improvement.
•  Traceability:
  The ability to track a batch throughout its lifecycle—from raw material receipt through manufacturing, testing, release, and distribution—ensuring complete and auditable documentation at every stage.
•  Marketing Authorization (MA):
  The official approval granted by a competent regulatory authority describing the product’s composition, process, packaging, labeling, and shelf life. All batch releases must comply with the current approved Marketing Authorization of the respective market.

PROCEDURE:

Compilation of Batch Documents:

• Production shall compile the BMR and BPR immediately upon completion of all operations.
• Production shall check all entries for completeness, correctness, and legibility.
• Yield reconciliation shall be performed and compared with approved limits; any deviation shall be recorded and investigated.
• The complete batch documentation shall be forwarded to QA for review along with all supporting attachments.

Quality Control Review:

• QC shall verify completion of all analytical testing as per specifications.
• The COA shall be prepared, reviewed, approved, and signed by authorized QC personnel.
• No COA shall be issued for a batch under OOS or pending investigation.
• One original COA shall be retained with the batch file and one copy shall accompany dispatch documents where required.
• All stability and control samples shall be collected and stored as per SOP.

Quality Assurance Review:

• QA shall review the complete batch documentation using the Batch Release Checklist.
• QA shall verify closure of all deviations, OOS/OOT, change controls, and CAPAs.
• QA shall ensure that any yield deviation or abnormal observation is supported by investigation and approval.
• QA shall confirm that labeling, packaging, and coding correspond to the approved artwork and master data.
• If any deficiency is observed, QA shall raise a query and the batch shall remain under “Hold” status until all discrepancies are resolved.

Authorization and Certification of Batch Release:

• After satisfactory QA review, the complete file shall be submitted to the Head – QA (Authorized Person).
• The Authorized Person shall review all records and ensure that:
• The batch has been manufactured and tested in accordance with GMP and the marketing authorization.
• All planned deviations and unplanned incidents have been assessed and resolved.
• All relevant data including COA, environmental conditions, equipment qualification, and personnel training are satisfactory.
• The Authorized Person shall certify batch release by signing and dating the Batch Release Authorization Form.
• Once certified, QA shall update the Batch Release Log and communicate the release status to Production, Warehouse, and Dispatch.
• No batch shall be dispatched unless it bears “Released” status authorized by the Head – QA.

Part Batch Release:

• In exceptional cases where part quantity is required urgently, the Head – QA may authorize a partial release.
• Such release shall be supported by written justification, and all documentation for the released portion shall be complete.
• The remaining quantity shall not be dispatched until final certification is completed.

Contract / Third-Party Products:

• QA shall ensure that contract sites are approved, audited, and covered under a valid Quality Agreement.
• The Authorized Person shall review the batch documents, COA, and inspection reports received from the contract manufacturer before release.
• Any deficiencies or critical observations shall be resolved prior to certification.

Record Retention and Archival:

• All released batch documents (BMR, BPR, COA, Authorization Form) shall be retained under QA custody in a secure record room.
• Retention period shall be at least one year after expiry or longer if required by the local regulatory authority.
• Electronic data shall be stored in validated systems with audit trail and restricted access.

Change Control and Product Quality Review Linkage:

• All post-release observations, trend deviations, or improvements identified shall be handled through the Change Control system.
• Batch release trends, deviation frequency, and CAPA effectiveness shall be reviewed annually as part of the Product Quality Review.

REFERENCE:

• EU-GMP Part I – Chapters 1 & 4
• EU-GMP Annex 16: Certification by a Qualified Person and Batch Release
• WHO TRS, Batch Release

RECORDS:

 REVISION HISTORY: