testing and approval rejection of bulk finish and packed drug products

1.0 Purpose
1.1 To describe a procedure for testing and approval or rejections of bulk and packed finished drug products.

2.0 Scope
2.1 This standard operating procedure is applicable for testing, approval or rejection of bulk and

packed finished drug products in QC laboratory at ABC Pvt. Ltd.

3.0 Responsibility
Officer QC/ Executive QC Preparation of SOP, Testing of material as per work allocation
Assistant Manager Reviewing and Training of SOP, Reviewing of data for batch release / reject
Manager QC Implementation of SOP
4.0 Accountability
4.1 Manager Quality Control is accountable for implementation and compliance with SOP.

5.0 Procedure
5.1 Finished drug products shall be sampled by QA person as per the respective sampling SOP.
5.2 Bulk Finish samples of Tablets (Coated/uncoated) and capsules shall be analyzed from pooled

composite sample of collected during compression, filling and coating stages, as appropriate.
5.3 Oral liquids and ointment shall be analyzed from the samples collected after the completion

of filling and packing operations.
5.4 The respective sample shall be distributed to the Analyst as per the SOP No. QCD-015.
5.5 QC officer shall perform the complete analysis of bulk finish drug products as per the standard

test procedure and all the raw data shall be recorded in the test protocols.
5.6 The protocol sheet along with scans; chromatograms, sampler report etc. shall be submitted

to any other second analyst for verification.
5.7 The Test protocol along with Certificate of Analysis (COA) and FTIR scans; chromatograms

and any other supporting documents shall then be handed over to Manager-QC or his authorized

nominee along with left over samples for approval of the material.
5.8 If any drug product does not comply with its specification in any of the prescribed tests and any

discrepancy observed during testing, it shall be immediately reported to the Manager QA / Manager QC.
5.9 Bulk Finish drug products, which fail to comply with its specification during initial analysis, shall

be subjected to handling of Out-of-specification (OOS) results as per SOP.
5.10 The Manger QC shall review the analytical data on certificate on Analysis, Raw data sheet,

samplers report, compliance of material as per specification and shall clear the lot if it complies.
5.11 After complying of the tests as prescribed in the respective specification, the finished product shall be approved.
5.12 Manager – QC /Manager – QA, shall finally approve or reject the finished drug product.
5.13 If drug product fails to the specification (even after OOS) and/or found un-satisfactory, the drug

product shall be rejected and investigation shall be carried out.

6.0 Reference
In House Specification

7.0 Attachments
Not Applicable

8.0 Distribution
Distribution of the controlled copy to concerned departments.
Additional copies may be issued for specific purpose.

9.0 Abbreviations
QA : Quality Assurance
QC : Quality Control
SOP : Standard Operating Procedure

10.0 Revision History