Procedure For Preparation of Specification and method of analysis

1.0 Objective
Objective of this Standard Operating Procedure is to provide guidelines for Preparation

of Specification and method of analysis.
2.0 Scope
Standard Operating Procedure is to provide guidelines for Preparation of Specification and

method of analysis in quality control department at abc Pvt. Ltd.
3.0 Responsibility
3.1 Executive – Quality Control.
3.2 In charge/Head-Quality Control.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
QC : Quality Control
CC NO : Change Control Number
cGMP : Current Good Manufacturing Practice
G : General
5.0 Procedure
5.1 Formal considerations
5.1.1 All the specifications / Test procedure have to be established in specific format All

Specifications / Standard Test Procedures shall have at least three signatures, out of which

one should be Quality Control Manager as a Department head, Q.A. Manager & any technical

staff who has prepared from the quality control department.
5.1.2 Every such document should have a unique reference number, which shall identify that

document. The document shall have a cross-reference.
5.1.3 All specification / standard test procedure shall be legibly / typed / computer printouts.
5.1.4 All specification / standard test procedure shall be signed by H.O.D. –Q.C., H.O.D.- Q.A.
5.1.5 Every such document should have a review period of two years when it shall be mandatatorly Reviewed.
5.2 Specification type
5.2.1 Q.C. Specification can be divided in to three types they are:
a) Raw material specification
b) Finished Product specification
c) Packing material specification
5.3 For Raw material specification
5.3.1 To be designed in a standard format.
5.3.2 Mention tests as specified in the monographs of IP / BP / USP / In-house as per requirement

of RM to be tested with reference to Drug license.
5.3.3 Fill up all the required details in the Raw material specification format as specified in the official.
5.3.4 Monograph or as per the In-house specification.
5.4 Finished product specification
5.4.1 To be designed in a standard format.
5.4.2 Mention tests as specified in the monographs of IP / BP / USP / In-house as per requirement

of Finished product to be tested, with reference to Drug license
5.4.3 Fill up all the required details in the finished product specification format as specified

in the official monograph or as per the In-house specification.
5.5 Packing material specification
5.5.1 To be designed in a standard format.
5.5.2 Mention tests specified as per the In-house specification for the packing material.
5.5.3 Select three samples of packing material from three different satisfactory

consignments and take a Performance test of all.
5.5.4 If the performance test is found satisfactory fix the limits for specified tests.
5.5.5 For text matters & colour coding in case of labels, cartons & leaflets refer approved art work for the same.
5.5.6 Fill up all the required details in the packing material specification format as per the In-house specification
5.5.7 Provisional limits to be set up under the consultation with user department till

the receipt & consumption of three satisfactory consignments.
5.6 Standard test procedure specification
5.6.1 To be designed in a standard format.
5.6.2 Describe tests as specified in the monographs of IP / BP / USP / In-house as

per requirement of RM and Finished product to be tested.
6.0 Forms and Records
6.1 None.
7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Control copy – Quality Assurance, Quality Control
8.0 History