sop for Continues Product Quality Review
1.1 To lay down a procedure for Continues Product Quality Review for the products manufactured in a every three months.
2.1 This Standard Operating Procedure is applicable for all products manufactured
3.1 Officer / Executive – QA shall be responsible for collection of relevant data and information required for preparing Continues Product Quality Review.
3.2 Head-Quality Assurance shall be responsible for assuring that all provisions of this SOP are fulfilled and approval of Continues Product Quality Review.
4.1 Head – QA
5.1 All manufactured batches in every three months (Jan to Mar., Apr. to Jun, Jul to Sept., and Oct. to Dec.)
shall be considered for preparing the CPQR.
5.2 The data shall be collected from BMR and BPR.
5.3 Following details to be covered in CPQR.
5.3.1 Product Description: Product details description i.e. Product name, Generic Name, Label Claim, Strength,
Batch Size, and any other specific information related to product shall be included.
5.3.2 Time Period Covered: Write the time period covered to prepare the CPQR.
5.3.3 Bulk Results and Observation: Collect the bulk data from BMR and BPR and summaries in CPQR.
5.3.4 Finished Product Result and Observation: Collect the finished data from BMR and BPR and summaries in CPQR.
5.3.5 % Yield: Collect the % yield data from BMR and BPR and summaries in CPQR..
5.4 CPQR shall be number as per following numbering system
CPQR No. : CPQR/001, Where
CPQR: Signifies Continues Product Quality Review
001: Sequential Number of the CPQR (i.e., from 001 to 999)
5.5 Frequency: At every three months + 15 days.
5.6 Prepare the CPQR as per Annexure I.
|S. No.||Abbreviations used||Full form of Abbreviation used|
|2.||SOP||Standard Operating Procedure|
|5.||BMR||Batch manufacturing record|
|6.||BPR||Batch packing records|
|7.||CPQR||Continues Product Quality Review|
7.0 ATTACHMENTS (ANNEXES) :
7.1 Annex –I : Continues Product Quality Review
8.0 REFERENCE :
|S. No.||Reference Title|
|1.0||As per WHO Guideline|
Annexure –I : Continues Product Quality Review