1.0 Purpose
1.1 To establish a system for proper compilation and Archiving of Batch Record of a Product for an appropriate period of time.
2.0 Scope
2.1 This procedure applies for all Batches
of finished Products manufactured by “NAME” Pharmaceuticals Ltd.
3.0 Responsibility
3.1 Quality
Assurance Personnel
4.0 Abbreviations and Definitions
4.1 Archive : A collection of documents or records of an organization.
4.2 BMR : Batch Manufacturing Records
4.3 BPR : Batch Packaging Records
5.0 Materials and Equipment
5.1 None
6.0 Precaution / Health and Safety Considerations
6.1
None
7.0 Procedure
7.1 Batch Records Compilation
7.1.1 After completion of batch, receive all records of the batch formulation such as BMR, BPR from Production,
Certificate of Analysis, QC test report and
microbiological test report (if required) from
QC Department.
7.1.2
Attach all the documents of a batch
along with the “BATCH DOCUMENTS REVIEW AND RELEASE
CHECKLIST OF FINISHED PRODUCT” form sequentially.
7.1.3 Check all the records according to the “BATCH DOCUMENTS REVIEW AND RELEASE CHECKLIST OF
FINISHED PRODUCT” properly and if any mistake found, it will be discussed with concerned department for remedial
action and if necessary, with Head of Quality Assurance.
7.1.4 After compilation of the above step, QA
Officer will give his/her signature in the place of “Checked & Compiled
By”.
7.1.5 The compiled “Batch Records” then sent to the Head of Quality Assurance or his / her signature “in the
place of “Approved
By”
7.2 Batch Records Archiving
7.2.1 Sent the compiled “Batch Records” for
Archiving after signature of the Head of Quality Assurance.
7.2.2 Record
the compiled Batch Records in the “Batch Records Register”.
7.2.3 Preserve the compiled Batch Records in the rack of archive room in a systematic way.
7.2.3.1 Compile Batch Records from different area,
such as solid, Liquid products separately and sequentially.
7.2.3.2 Batch Records of a month serially.
7.2.3.3 Batch Records of different months separately.
7.2.3.4 Batch Records of different years separately.
7.3
Archiving all Batch Records after
one year from the date of expiry
8.0 Reference Document
8.1 In-house
9.0 Annexure
9.1 None
10.0 Revision History
|
Version No. |
Brief Reason for the Revision |
Effective Date |
Remarks |
|
01. |
New |
|
|
|
|
|
|
|
11.0 Training
11.1 Training is required for Officers / Sr.
Officers of QA departments, trained by Head of Quality Assurance.
