sop for Procedure For Conditional Release

1.0 Objective
To lay down a procedure for conditional release of raw material and finished product.
2.0 Scope
This Standard Operating Procedure (SOP) is applicable for conditional release of raw materials and finished

products of tablet, capsule, liquid, External to be followed at formulation plant of ABC Pvt. Ltd. Roorkee.
3.0 Responsibility
3.1 Production Officer / Executive shall be responsible for giving filling the conditional release

form of raw material and finished products.
3.2 Officer / Executive QA shall be responsible for verifying the conditional release form.
3.3 Head / in charge, Quality assurance or his/ her designee shall be responsible for compliance of SOP.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
QA : Quality Assurance
No. : Number
BPCR : Batch Production and Control Record
MLT : Microbial Limit Test
5.0 Procedure
5.1 Conditional release procedure for raw material
5.1.1 Production department shall initiate the conditional release note for raw material as per annexure-2.
5.1.2 Conditional release shall be given for raw materials which are received from approved vendors only.
5.1.3 Conditional release shall be given only material/ product which has test for sterility / MLT.
5.1.4 Conditional release shall be given only after 07 days of sterility analysis and in case of raw

material having MLT shall be given after 03 days of analysis.
5.1.5 Finished product prepared from conditional released sterile raw material, shall be

released only after the complete sterility analysis of raw material.
5.1.6 Finished product prepared from conditional released raw material for MLT, shall be released

only after the complete MLT analysis of raw material.
5.1.7 In case of raw material fails in sterility / MLT, finished product manufactured from

conditional released raw material shall be destroyed.
5.1.8 In case of urgency / market requirement, production department shall raise the deviation form

for release of raw material for further processing with proper justification. If possible copy

of urgent requirement from marketing / planning department shall also be attached

with the deviation form.
5.1.9 After authorization of conditional release note by the QA Head, QA Officer / Executive shall

give the conditional release note no. and record the entry in “Conditional release record of Raw material” as per annexure- 4.
5.1.10 A unique numbering system shall be followed for giving number to conditional release note as where
stand for conditional release note for raw material.
“/” stand for separator
“12” stand for last two digit of current year
“/” stand for separator
“001” stand for serial number
5.1.11 After authorization from Head QA, raw material shall be used for further processing.
5.1.12 Distribution record of conditional release shall be as follows
Original copy – QA Department
Photo copy – In BPCR, Warehouse, Quality Control department
5.2 Conditional release procedure for finished product
5.2.1 Production department / warehouse shall initiate the conditional release note for

finished product as per annexure-1.
5.2.2 Conditional release shall be given only for transit of finished product to depot /C&F.
5.2.3 Conditional release shall be given only for sterility test and MLT of finished product.
5.2.4 Conditional release shall be given only after successful completion of 07 days of sterility

analysis and after 03 days of MLT analysis and after proper justification by the initiating department.
5.2.5 No conditional release shall be given for other pharmacopeias specifications.
5.2.6 Conditional release shall be based on release of finished products for chemical analysis from QC.
5.2.7 QC manager shall write date of final release based on sterility and MLT test, after date of final

release; product shall be released in market for sale.
5.2.8 After authorization of conditional release note by the QA Head, QA Officer / Executive shall give

the conditional release note no. and record the entry in “Conditional release record of Finished Product” as per annexure- 3.
5.2.9 A unique numbering system shall be followed for giving number to conditional release note as where
“CRNF” stand for conditional release note for finished product.
“/” stand for separator
“12” stand for last two digit of current year
“/” stand for separator
“001” stand for serial number
5.2.10 After authorization from Head QA, finished products shall be transferred from factory
to depot / C & F along with a copy of conditional release note.
5.2.11 Distribution record of conditional release shall be as follows
Original copy – QA Department
Photo copy – In BPCR, FG Warehouse, with consignment to depot / C & F
6.0 Forms and Record:
6.1 Conditional release note for finished product – Annexure- 1
6.2 Conditional release note for raw material – Annexure- 2
6.3 Conditional release record for finished product – Annexure- 3
6.4 Conditional release record for raw material – Annexure- 4
7.0 Distribution:
7.1 Master Copy – Documentation Cell (Quality Assurance)
7.2 Controlled Copy – Quality Assurance, Production and Warehouse
8.0 History:

Revision Number	Details For Change	Reason for Revision
00	New SOP	NA

sop for Procedure For Conditional Release

Reason for Revision

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