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SOP_QA_31_Numbering Specification

This Standard Operating Procedure (SOP) outlines the numbering system for specifications in Quality Control, detailing the responsibilities and procedures for categorizing raw materials, packaging materials, finished products, stability specifications, intermediate specifications, and in-process specifications. Each category has a specific alphanumerical format for identification, including prefixes and revision numbering. The SOP is effective from April 15, 2012, with a revision due in March 2014.

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3 views

SOP_QA_31_Numbering Specification

This Standard Operating Procedure (SOP) outlines the numbering system for specifications in Quality Control, detailing the responsibilities and procedures for categorizing raw materials, packaging materials, finished products, stability specifications, intermediate specifications, and in-process specifications. Each category has a specific alphanumerical format for identification, including prefixes and revision numbering. The SOP is effective from April 15, 2012, with a revision due in March 2014.

Uploaded by

Vidya
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOC, PDF, TXT or read online on Scribd
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DEPARTMENT QULAITY ASSURANCE Page. No.

1 of 2
AREA QUALITY CONTROL SOP No.: SOP/QA01
REVISION No.: 00
NUMBERING SYSTEM OF SUPERSEDES: SOP/QC01/03
SUBJECT SPECIFICATION EFFECTIVE DATE: 15.04.2012
REVISION DUE : March 2014
PREPARED BY CHECKED BY APPROVED BY AUTHORISED BY
SIGNATURE

NAME

Designation

DATE

1. OBJECTIVE:
The objective of this Standard Operating Procedure (SOP) is to describe the numbering system of
specification.
2. SCOPE:
This SOP is applicable to numbering system of specification in QC.
3. RESPONSIBILITY:.
3.1 Head QC is responsible for maintenance of the numbering system of specification.
4. ACCOUNTABILITY:
Head - Quality Control
5. Procedure:
5.1 Raw material and Packaging Material:
5.2 All Raw materials / Packaging materials shall be grouped in alphanumerical order are serially numbered
with a prefix of the R alphabet, i.e. R-00101

5.3 All RM grouped product wise and listed, refer Annexure 1, e.g. R-00101 to R-00112 indicates total raw
material grouped product wise for “TRICLOSAN” are twelve.

5.4 All serial numbers of Raw / Packaging materials mentioned above shall be prefixed by a stroke “ - “ by
either of the following:

“KRM” in case of Raw Material

“KPM” in case of Packaging Material

5.5 Any revision in the existing Raw / Packaging material specification shall bear the same serial number
followed by stroke “ / “ and revision number starts from 00 for New.

5.5.1 For example KRM/R-00102 Indicates the specification of raw material R-00102

5.5.2 KRM/R-00102 -01 and KRM/R-00102-02 Indicates the first and second revision of specification of raw
material

R- 00102.

5.6 Finished Product:


Code number of finished products mentioned in SOP No. SOP/QA03/04 shall be prefixed by a stroke
and appropriate
Pharmacopoeia code from the following:
BP : Specification as per British Pharmacopoeia
USP : Specification as per United States Pharmacopoeia
EP : Specification as per European Pharmacopoeia
IP : Specification as per Indian Pharmacopoeia
IH : In-House specification and Party’s specifications
JP : Specification as per Japanese Pharmacopoeia
BP/USP : Specification as per British Pharmacopoeia and U.S. Pharmacopoeia
M : Specific Marketing requirements for specification

5.6.1 All numbers are prefixed by stroke and `FPS’, where `FPS’ stands for finished product specification.
For example: FPS/USP/K001 indicates the finished product specification for product `Triclosan’ as per
United States Pharmacopoeia.

5.6.2 Any revision in the existing finished product specification will bear the same serial followed by stroke
and revision number.

For example: FPS/USP/K001-01 and FPS/USP/K001-02 indicates the first revision and second
revision of FPS/USP/K001.

5.6.3 For any specific customer requirements the finished product specification number shall remain same,
only `M’ will be suffix after the Pharmacopoeia status code.

For example: FPS/USP/M/SCL001

5.7 Stability Specification:


5.7.1 Select the Product code from SOP No. : SOP/QA03/04.
5.7.2 The above code shall be prefixed by `STB’ where `STB’ stands for Stability.

For example: `STB/K001’ indicates the stability specification of the product `K001’ i.e. Triclosan.

5.8 Intermediate Specifications:


5.8.1 Select the intermediate code from SOP No. : SOP/QA03/04.
5.8.2The above code shall be prefixed by `INT’ where `INT’ stands for Intermediate.

For example: `INT/K0011’ indicates the first intermediate of the product `K001’ i.e. Triclosan.

`INT/K0012’ indicates the second intermediate of the product `K001’.

For US Batch: `INT/K0011U’ indicates the first intermediate of the product `K001U’ i.e. Triclosan.

`INT/K0012U’ indicates the second intermediate of the product `K001U’.


5.9 In-process Specifications:
5.9.1 The same numbering system as intermediates is applied for In-process samples specifications. Only
prefix will be changed to “IP” instead of “INT”. All In-Process samples will be identified by suffixing A,
B, C, D to that particular Intermediates No.
For example: IPQC/K0011A indicates the specification of first in-process samples of Intermediate
`K0011’.

Numbering requirement for the products which are not listed above or for any special requirements
the numbering shall be made as per the instructions of Head - QA.

6.0 Important:
In all other document of the factory where a reference is made to any raw material or finished product
specification, it must be noted that only the basic specification number without the revision number
shall be stated. It must be clearly understood that at any point of time the specification applicable shall
be the one currently, in use.

7.0 TRAINING:

Trainer - Head Quality Control.

Trainees – Chemists / Sr. Chemist.

8.0 DISTRIBUTION:

Original Copy : Head – Quality Assurance


Certified Copy No. 1 : Head – Quality Control (RM)
Certified Copy No. 2 : Head – Quality Control (FG)
Certified Copy No. 3 : Head – R&D Analytical
9.0 ANNEXURES: Nil

10.0 REFERENCE:

In house

11.0 REVISION HISTORY:


Revision Number Effective Date Revision Details Reason for Revision Authorized By
DEPARTMENT QULAITY ASSURANCE Page. No. 5 of 2
AREA QUALITY CONTROL SOP No.: SOP/QA01
REVISION No.: 00
NUMBERING SYSTEM OF SUPERSEDES: SOP/QC01/03
SUBJECT SPECIFICATION EFFECTIVE DATE: 15.04.2012
REVISION DUE : March 2014
PREPARED BY CHECKED BY APPROVED BY AUTHORISED BY
SIGNATURE

NAME

Designation

DATE
DEPARTMENT QULAITY ASSURANCE Page. No. 6 of 2
AREA QUALITY CONTROL SOP No.: SOP/QA01
REVISION No.: 00
NUMBERING SYSTEM OF SUPERSEDES: SOP/QC01/03
SUBJECT SPECIFICATION EFFECTIVE DATE: 15.04.2012
REVISION DUE : March 2014
PREPARED BY CHECKED BY APPROVED BY AUTHORISED BY
SIGNATURE

NAME

Designation

DATE

ANNEXURE – 1

LIST OF RAW MATERIALS WITH RM CODE

S.NO NAME OF RAW MATERIAL CODE NO USED FOR PRODUCT

1 2,4 – DICHLOROPHENOL R-00101 TROCLOSAN

2 2,5 – DICHLORONITRIBENZENE R-00102 TROCLOSAN

3 ACETIC ACID R-00103 TROCLOSAN

4 IRON POWDER R-00104 TROCLOSAN

5 HYDROCHLOROC ACID R-00105 TROCLOSAN

6 HEXANE R-00106 TROCLOSAN

7 POTASSIUM HYDROXIDE R-00107 TROCLOSAN

8 SODIUM CHLORIDE R-00108 TROCLOSAN

9 SODIUM HYDROXIDE R-00109 TROCLOSAN

10 SODIUM NITRITE R-00110 TROCLOSAN

11 SULPHURIC ACID R-00111 TROCLOSAN

12 PERCHLOROETHYLENE R-00112 TROCLOSAN

13 PROCESS WATER R-00113 TROCLOSAN

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