Finished Product Release

1.0     Purpose

1.1        To describe the procedure for finished product release.

 

2.0     Scope 

2.1      This procedure is applicable for all batches of finished product that are manufactured in NAME  Pharmaceuticals Ltd.

 

3.0     Responsibility

3.1      Head of Production or his/her designee shall be responsible for review & sending the batch 

Production Record (BMR/BPR) to QA for review and approval.

3.2          Head of Quality Control or his/her designee shall be responsible to send all analytical report to QA 

relevant to batch release.

3.3          Head of Quality Assurance or his/her designee shall be responsible for review the Batch

 document (BMR  & BPR) and release the batch.

 

4.0      Abbreviations and Definitions 

4.1        BMR     :           Batch Manufacturing Records

4.2        BPR     :           Batch Packaging Records

4.3        IPC       :           In Process Control

 

5.0       Materials and Equipment 

5.1        Finished product inspection seal and part batch release seal

           

6.0     Precaution / Health and Safety Considerations 

6.1        All relevant documents must be checked properly before release of a product.

 

7.0       Procedure 

7.1      After completion of batch packing, Officer /  Sr. Officer, Production /above shall forward a batch

 release request form with completed Batch Production Records (BMR & BPR) to QA Department as 

per Annexure –I.

 

7.2        After getting request, Officer/ Sr. Officer, Quality Assurance/ above shall perform the finished

 packs inspection and verify quantity of finished packs as per request by production department that will 

be released.

 

7.3        The finished packs inspection shall be inspected as per Annexure- II. During finished packs 

inspection Officer/ Sr. Officer, Quality Assurance/ above shall stamp on master carton as “INSPECTED” with

 sign & date. The total number of master carton will be checked as per following table and at least 02 

inner cartons per master carton shall be checked during inspection.

 

No of master carton	Inspection No
Below or equal 50	02
Below or equal 100	03
Below or equal 250	04
>250	05

 

7.4        Head of QA or his/her designee shall verify the Batch Production Record (BMR & BPR) and all

 the physical, chemical  and  microbiological (if required) test report of intermediate, bulk and finished product

 as per checklist (Annexure –III)  for correct entries, yield, deviations (if any), IPC checks etc.

 

7.5        If the all-checklist results are found satisfactory, Officer/ Sr. Officer, Quality Assurance/ above of 

QA Department shall prepare Finished Product Released Note (Annexure – IV) in two copies (one original & 

one photocopy) & forward the photocopy to Warehouse / Production Department for release processing

 and original copy shall be attached to batch production record.

 

7.6        Completed batch production record shall be kept under lock and key in the custody of QA Department 

and archive the batch document for a period of one year after expiry of shelf life of the product.

 

7.7        In general case part batch release is not recommended. But if any part batch released may be 

required on emergency situation such as institutional sales, export release or other cases then it may be

 accepted with proper justification.

 

7.8        In case of part batch release (packing not completed), Officer/ Sr. Officer /above of 

Production Department shall forward a batch release request form (Annexure-I) as per procedure

mentioned above by stamping “PART BATCH RELEASE” by mentioning part number on batch release 

request form to QA department for inspection.

 

7.9        After getting request for part batch release, Officer/ Sr. Officer, Quality Assurance / above of 

QA Department  shall check the all physical, chemical and microbiological (if required) test results of

 intermediate, bulk and finished product and review the all critical process parameters of Batch 

Manufacturing Record (BMR).

 

7.10      If the all physical, chemical and microbiological (if required) test results and process parameters of 

Batch Manufacturing Record (BMR) are found satisfactory, then Officer/ Sr. Officer /above of QA Department 

shall inspect & verify quantity of finished packs as per request by production department that will be released.

 

7.11      After inspection, Officer/ Sr. Officer /above of QA Department shall prepare Finished Product 

Released Note as per Annexure – IV by stamping as “PART BATCH RELEASE” on finished product release note.

 

7.12      The batch release request form and finished product release note for part batch release shall be kept

 in QA department and will be attached to batch document during final rerelease of the respective batch.

 

8.0      Reference Document 

8.1        WHO Guidelines, volume 2, second edition.

8.2        ISO 9001 guidelines

8.3        In-house procedure;

 

9.0       Annexure

 

9.1        Annexure-I        : “BATCH RELEASE REQUEST FORM”

9.2        Annexure-II        : “FINISHED PACKS INSPECTION SHEET”

9.3        Annexure-III       : “BATCH DOCUMENTS REVIEW AND CHESTLIST OF FINISHED PRODUCT”

9.4        Annexure-IV      : “FINISHED PRODUCT RELEASE NOTE”

 

 

10.0      Revision History

 

Version No.	Brief Reason for the Revision	Effective Date	Remarks
01.	New

 

 

 

 

 

 

 

 

11.0    Training 

11.1      Head of Quality Assurance or his/her nominee shall give the SOP training before effective date.

Annexure-I 

 

BATCH RELEASE REQUEST FORM
Form No.		Revision No.	00	Effective Date		Page 1 of 1

From	Production Department
To	Quality Assurance Department
Product Name:				Batch No.:
Mfg. Date:		Exp. Date:		Batch size (Packs):
Pack size (Local):		Export:		Physician:

To be released (Local):		X		+	(loose)	=	Packs
To be released (Export):		X		+	(loose)	=	Packs
To be released (Physician):		X		+	(loose)	=	Packs

Requested By	Checked By
Officer / Above, Production	Officer / Above, Quality Assurance
QA Comment:

 

 

 

 

Annexure-II

 

 

FINISHED PRODUCT INSPECTION SHEET
Form No.		Revision No.	00	Effective Date		Page 1 of 1

 

Product Name :				Batch No.:
Mfg. Date:		Exp. Date:		Batch size (Packs):
No. of packs(Local):		Export :		Physician :
Pack size (Local):		Export :		Physician :

Sl. No.	Items	Parameters	Observations
			IN (I)	IN (II)	IN (III)	IN (IV)	IN (V)
01	Master Carton	Code & Appearance of Master Carton is OK	Š Yes Š No	Š Yes Š No	Š Yes Š No	Š Yes Š No	Š Yes Š No
		Master Carton No.
		Product Name, Batch No., Mfg. Date & Exp. Date of   MC label is OK	Š Yes Š No	Š Yes Š No	Š Yes Š No	Š Yes Š No	Š Yes Š No
		Number of Inner Cartons or units /MC
02	Inner Carton / unit pack	Product Name, Appearance & Code of Inner Carton: OK	Š Yes Š No	Š Yes Š No	Š Yes Š No	Š Yes Š No	Š Yes Š No
		Batch No., Mfg. Date, Exp. Date & Price printed on Inner Carton: OK	Š Yes Š No	Š Yes Š No	Š Yes Š No	Š Yes Š No	Š Yes Š No
		No of Unit Quantity/Inner Carton
		Ancillary materials (leaflet /Spoon / Measuring cup / Dropper / Hologram Sticker/ others …………… …………..……………………………. ) are present	Š Yes Š No	Š Yes Š No	Š Yes Š No	Š Yes Š No	Š Yes Š No
		No. of  Inner cartons/unit packs checked
03	Blister / PET /glass bottle / container	Appearance is OK	Š Yes Š No	Š Yes Š No	Š Yes Š No	Š Yes Š No	Š Yes Š No
		Batch No./ Mfg. Date/ Exp. Date embossed/printed is OK	Š Yes Š No	Š Yes Š No	Š Yes Š No	Š Yes Š No	Š Yes Š No
		Sealing is OK	Š Yes Š No	Š Yes Š No	Š Yes Š No	Š Yes Š No	Š Yes Š No
		Volume (Visual check) / unit quantity (Tablet / Capsule) per primary packaging is OK	Š Yes Š No	Š Yes Š No	Š Yes Š No	Š Yes Š No	Š Yes Š No
		Caps / Closures is OK	Š Yes Š No	Š Yes Š No	Š Yes Š No	Š Yes Š No	Š Yes Š No
04	Bottle/ Container Label	Batch No./ Mfg. Date/ Exp. Date / Price printed on Label is OK	Š Yes Š No	Š Yes Š No	Š Yes Š No	Š Yes Š No	Š Yes Š No
		No. of bottle/container checked
		Adhesiveness & Positioning is ok	Š Yes Š No	Š Yes Š No	Š Yes Š No	Š Yes Š No	Š Yes Š No
05	Inspected By (Sign & Date)

   Remarks:

   NB: OK = All Complies; NA = Not Applicable; IN=Inspection Number              

 

Annexure-III

 

 

BATCH DOCUMENTS REVIEW AND CHESTLIST OF FINISHED PRODUCT
Form No.		Revision No.		Effective Date		Page 1 of 2

Product Name
Product Code		Batch Size		Mfg. Date
Batch No.		Pack Size		Exp. Date

 

1.0 Documents Regarding Manufacturing and Analysis

SI. No.	Document Description	Parameters to be reviewed	Reviewed on	Remarks	Reviewed by (Initial)
1.1	Batch Manufacturing Record (BMR)	01. Dispensing RMs and its        Calculation 02. Line Clearance 03. Mixing time 04. Machine RPM 05. Temperature (Drying) 06. Drying Time 07. Environmental Condition 08. Manufacturing Procedure 09.Reconciliation 10. In Process Parameters
1.2	Certificate of Analysis - Chemical	01. Physical Parameters 02. Chemical Parameters
1.3	Product Analysis Data Sheet	01. Assay 02. Content Uniformity 03. Dissolution
1.4	Certificate of Analysis - Microbial	01. Microbial Parameters

          2.0 Documents Regarding Packaging

SI. No.	Document Description	Parameters to be reviewed	Reviewed on	Remarks	Reviewed by (Initial)
2.1	Batch Packaging Record	01. Dispensing of PMs 02. Line Clearance 03. Environmental Condition 04. In Process checking 05. In Process machine        parameter 06. Reconciliation
2.2	Specimen Of Packaging Materials	Batch No              :                Mfg. Date             :  Exp. Date             :                IP / MRP               :
2.3	Finished Product Transfer Note	01. Quantity of Finished Product

 

BATCH DOCUMENTS REVIEW AND CHESTLIST OF FINISHED PRODUCT
Form No.		Revision No.		Effective Date		Page 2 of 2

 3.0 QMS Status of the batch: 

Note any Deviation / OOS / Change Request regarding the batch and attach the copy;

 4.0  Release Status of the batch:

RELEASE STATUS
Release No.	Date of Release	Commercial		Physician’s Sample	Signature & Date (QA Officer)
		Local	Export
		(As Finished Pack)
Part-1
Part-2
Part-3
Part-4
Part-5
Total

Batch Qty. (In Pcs)	Released Qty. (In Pcs)	Remarks

5.0 Comments of QA:

Comments and Sign (By QA):

 

6.0 Batch Document Compilation:

 

Compiled and checked by Officer/ Sr. Officer, QA (Sign and Date):
Approved By Head of Quality Assurance (Sign and Date):

                                                                                                                                                                                                                                               

 

 

 

 

Annexure-IV 

FINISHED PRODUCT RELEASE NOTE
Form No.	F/SPL/QA/014/01	Revision No.	00	Effective Date		Page 1 of 1

 

From :  Quality Assurance Department	To :  Production /  Warehouse Department
Date:
Product Name:	Batch No.:
Manufacturing Date:	Expiry Date:
Batch Size (Local):                                   Packs	Lab / QC Reference No.:
Release Quantity:	Pack Size:
Local          :                                         Packs	Local          :
Export        :                                         Packs	Export        :
Physician   :                                         Packs	Physician   :
Remarks:
Prepared By:        Officer / Above, Quality Assurance	Released By :        Head of Quality Assurance