sop for conditional release in pharma

1.0 OBJECTIVE
1.1 The objective of this SOP is to define the procedure for conditional release of raw materials and finished products.
2.0 SCOPE
2.1 This SOP is applicable for conditional release of raw materials and finished products
3.0 RESPONSIBILITY
3.1 Officer-Quality Assurance – Prepare the SOP and follow-up the SOP accordingly.
3.2 Asst. Manager-Quality Assurance / Production -Provide the support to the implementation of SOP and maintained the records.
4.0 ACCOUNTABILITY
4.1 Head – Quality Assurance Department / Chief Executive Officer
5.0 REFERENCE(S)
5.1 Not Applicable

6.0 PROCEDURE
6.1 CONDITIONAL RELEASE OF STERILE RAW MATERIALS:
6.1.1 Conditional release of sterile raw material shall be given only for Sterility test/MLT in case of urgent market requirement of finished product.
6.1.2 QA personnel shell put conditional release number with date on the conditional release form for raw material as per Format on the basic of market requirement of product.
6.1.3 A unique numbering system shall be followed for giving number to conditional release note e.g. CRNR /15/ 001
Where,
‘CRNR’ : Stand for Conditional Release Note for Raw Material
‘/’ : Stand for Separator
‘15’ : Stand for last two digits of Current Year i.e., 2015….
‘001’ : Stand for Serial Number
6.1.4 QA person shall issue conditional release note to production department and record the entry in conditional release record for raw materials, as per Format No.
6.1.5 Production department shall fill the form and send to QC department.
6.1.6 QC Head shall write the comments and date of final release on the conditional release note and forward to QA department.
6.1.7 Head QA shall check & write remarks and give for approval for conditional release of raw material and send to Chief Executive Officer for signature.
6.1.8 After approval and authorization of conditional release form, QA person make two photocopies of approved form.
6.1.9 One copy shall be issued to QC department for releasing of product and second copy issued to production department for manufacturing of product.
6.1.10 Original Copy shall retain with QA Documentation Cell.
6.1.11 Conditional Release shall be given only for Sterility Analysis and MLT.as per testing validation.
6.1.12 The finished product prepared from conditionally released sterile RM shall be released only after the complete sterility analysis of RM i.e. after 14 days and MLT after 5 days.
6.1.13 If conditionally released raw materials failed in sterility test all the manufactured Finished Products shall be destroyed.
6.2 CONDITIONAL RELEASE OF FINISHED PRODUCTS:
6.2.1 Conditional release shall be given only for transit of finished products to customer depot / C & F.
6.2.2 Conditional release shall be given only for release of finished product for Sterility Test.

6.2.4 Conditional release of finished product shall be given only for Sterility test in case of urgent market requirement.
6.2.5 Conditional release of finished product shall be based on chemical analysis from QC department.
6.2.6 QA personnel shell put conditional release number with date on the conditional release form for finished product as per Format on the basic of market requirement of product.
6.2.7 A unique numbering system shall be followed for giving number to conditional release note for finished product e.g. CRNF /15/ 001
Where,
‘CRNF’ : Stand for Conditional Release Note for Finished Product
‘/’ : Stand for Separator
‘15’ : Stand for last two digits of Current Year i.e., 2015….
‘001’ : Stand for Serial Number
6.2.8 QA person shall issue conditional release note to production department and record the entry in conditional release record for finished product, as per
6.2.9 Production department shall fill the form and send to QC department.
6.2.10 QC Manager shall write the comments and date of final release on the conditional release note and forward to QA department.
6.2.11 Head QA shall check & write remarks and give for approval for conditional release of raw material and send to Chief Executive Officer for signature.
6.2.12 After approval and authorization of conditional release form QA person make two photocopies of approved form.
6.2.13 One copy shall be issued to QC department for releasing of product and second copy of Conditional Release Note shall be sent to Customer Depot/C&F/Warehouse along with consignment.
6.2.14 Original Copy shall retain with QA Documentation Cell.
6.2.15 Conditionally released batch shall be released in market from depot only after complies the sterility test.
6.2.16 If product does not complies the tests of sterility Head QA shall immediately intimate to Customer Depot/C&F/Warehouse for return the goods to factory.

7.0 ABBREVIATIONS

SOP : Standard Operating Procedure
QA : Quality Assurance
QC : Quality Control
C&F : Carrying and Forwarding
8.0 ANNEXURE

Annexure No.	Title of Annexure
Annexure -I	Conditional Release Note for Raw Material
Annexure -II	Conditional Release Record for Raw Materials
Annexure -III	Conditional Release Note for Finished Products
Annexure -IV	Conditional Release Record for Finished Goods