Procedure for addition of Recovery

1.0	PURPOSE To lay down the procedure to document and to control batch recovery to ensure that quality, safety, purity and efficiency is maintained and entire activity or under control.
2.0	SCOPE This SOP is applicable and covers all the product/ dosage form manufactured by Company name
3.0	RESPONSIBILITY 3.1 Production Chemist 3.1.1 To identify and control the recovery of the batch in conjunction with QA chemist. 3.2 QA Chemist 3.2.1 Ensure and review the status of recovery with respect to their impact on quality and GMP compliance of the affected batches.
4.0	ACCOUNTABILITY  Head Quality Assurance
5.0	PROCEDURE
5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9	Step should be taken with extra precaution to avoid generation of undue recovery. Collect the recovery from unavoidable source into the polybags in case of powder and into cleaned SS vessel in case of oral liquid with proper identification and precaution. Recovered the liquid from defective filled bottle in a cleaned SS stainless steel vessel and filter under controlled condition with proper precaution and collect into a cleaned SS container. Collected liquid Should be filled into main Filling tank. In case of recovered defective tablet crush the recovered tablet in multimill and shift it through proper mesh sized sifter, ensure that no fragment of tablet shall be passed through the sieve. Weight the recovered powder And record. Do not hold any recovery generated for more than 3 month, avoid undue storage of recovery, recovery should if generated must be used in immediate next batch. if Head QA approve the same.  Get the result of recovery analyzed by the QC. Specify the batch no. in which recovery is to be added, but not more than 5 % of the batch size. Get the comment of Head QA for the suitability of the use/ addition of recovery and quantity. Head QA on the basis of investigation and analysis of analytical result on recovery and affect on the quality, safety, purity and efficiency of product approve/rejected the request of addition of recovery.
6.0	REFERENCES     NIL

7.0

ANNEXURES

Annexure No.	Title of Annexure	Format No.
Annexure I	RECOVERY PROCESSING REQUEST FORM	QA/018/F01-02

8.0	ABBREVIATIONS

Abbreviations						Full Forms
SOP						Standard Operating Procedure
QA						Quality Assurance
QC						Quality Control
9.0	DISTRIBUTION
Master Copy							Head Quality Assurance Department
Controlled office Copy No. 1							Head Quality Assurance Deptt.
Controlled office Copy No. 2							Head Production ( Tablet)
Controlled office Copy No. 3							Head Production ( Liquid)
10.0		REVISION HISTORY
S.No.			Revision No.	Effective Date	Reason for Revision			Details of Change	Authorized By (sign & Date)

           

Annexure I

RECOVERY PROCESSING REQUEST FORM

A. RECOVERY PROCESSING REQUEST
Product Name		Batch No.
Recovered Qty
Reason for recovery
Preventive and corrective action proposed
Initiated By	Name:		Sign  & Date:
Checked By	Name:		Sign  & Date:
B. Investigation By QA :                                                                                                                                                                       Sign & date
C. Comment of Head QC: Comment:                                                                                                                                                                      Sign & date