1.0 OBJECTIVE
To lay down a standard procedure for the preparation of Standard Testing Procedure for Raw Material,
Bulk product, Intermediate product, finished product.
2.0 SCOPE
This SOP is applicable for the preparation of Standard Testing Procedure for Raw Material, Bulk
product, Intermediate product, finished product in Quality Control Laboratory
3.0 RESPONSIBILITY
Officers/ Executive – Quality Control shall be responsible for follow the procedure mentioned in this SOP.
4.0 ACCOUNTABILITTY
Head QC and Head QA shall be accountable for compliance of this SOP.
5.0 ATTACHMENTS
Standard testing procedure for Raw Materials Attachment-I
Standard testing procedure for Bulk Products Attachment-II
Standard testing procedure for Intermediate Products (Uncoated) Attachment-III
Standard testing procedure for Intermediate Products Attachment-IV
(Coated, Filled Capsules, Sachet, Syrup) Standard testing procedure for Finished Products Attachment-V
6.0 PROCEDURE
6.1 Quality Control Department shall prepare the STP for Raw Material, Bulk product, Intermediate Product (uncoated), Intermediate Product (Coated, Filled Capsules, Sachet, Syrup), Finished product as Per Attachment-I, II, III, IV and V.
6.2 The STP shall be prepared by using reference pharmacopoeia or other Reference source.
6.3 Each STP shall have a unique number that is given below:-
STP/RM/000 (For Raw material)
STP/BL/T/000 (For Bulk Product)
STP/IM/T/000 (For Intermediate Product of Uncoated Tablets)
STP/SF/T/000 (For Intermediate Product of Coated Tablets, Capsules, Sachet, Liquid)
STP/FP/T/000 (For Finished Product)
Ex.- STP/FP/T/000, where STP/ for Standard testing procedure, FP/ for Finished products, T/ for Tablets and the 000 for serial number. In case of Syrup, Sachet and Capsules T/ will be replace by C/ for Capsules, ST/ for Sachet and S/ for Syrup.
6.4 Once a number is allocated to any STP the same number shall not be repeated to any other STP.
6.5 All the STP shall be approved and controlled by Quality Assurance Department.
6.6 All the STP shall be revised whenever there is any change in pharmacopoeia or relevant Sources.
6.7 Any change in STP shall be done through change control procedure.
7.0 REFEENCES
In-house
8.0 ABBREVIATIONS
SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
STP: Standard Testing Procedure
9.0 DISTRIBUTION LIST
Quality Assurance
Quality Control
10.0 HISTORY OF REVISION
| Version No. | Effective Date | Reason for Revision |
| 00 | 10-11-2015 | New SOP |
| 01 | 17-11-2017 | Periodic Revision |
