SOP The preparation and issuance of specification and test method

SOP The preparation and issuance of specification and test method

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6 4.0 PROCEDURE

0.0         
what

This document details the
procedure for the preparation and issuance of specification and test method for
Raw material, packing material, intermediate and finished products.

           

1.0         
why

It is the policy of ABC
pharmaceuticals that the written procedure shall be followed for preparation of
specification and test method to ensure the control and consistency of the
documents and also to meet the cGMP requirements.

           

2.0         
when

This procedure is to be
applied at the time of preparation and issuance of specification and test
methods for Raw materials, packing materials, intermediates and finished
product.

3.0         
RESPONSIBILITY

Persons along with their
responsibilities are given below:

S. No

Designation

Responsibility

01

Executive  – Corporate Quality Assurance

Preparation of SOP

02

Manager – Quality
Assurance

To follow SOP accordingly

03

Manager              Corporate Quality Assurance

To ensure implementation of SOP



4.0         
PROCEDURE



5.0.1    The preparation of specification and test method (STP)
shall follow the following procedure.

4.1         
FIRST PAGE

4.1.1     
Header Information

4.1.1.1    
Header shall have monogram of
company with complete address on the left.

4.1.1.2    
In the right of header a table
shall have following information.

Code

:

(STP code No.)

Issue No.

:

(Version No. of STP)

Effective Date

:

(Effective date of STP)

                       

4.1.1.3    
Code Number

4.1.1.3.1   
Raw Materials

·        
All raw materials
shall be coded as AP/RMS-XXX.

·        
AP stand for ABC
pharmaceuticals.

·        
RMS stand for raw
materials specification.

·        
XXX is the sequence
number of raw material STP like 001,002…prepared first time in APL.

4.1.1.3.2    Packing Materials

·        
Test specification of packing materials shall be coded as AP/PMS-XXX.

·        
APL stand for ABC pharmaceuticals.

·        
PMS stand for packing materials specification.

·        
XXX is the sequence number of packing material STP like 001,002…prepared
first time in APL
.

4.1.1.3.3    Intermediate and finished products

·        
Test specification of product shall be coded as AP/QC/MGR-XXX.

·        
APL stand for ABC pharmaceuticals.

·        
MGR stands for manufactured product.

·        
XXX is the sequence number of product STP   like 001,002…prepared first time in APL.

4.1.1.4    
Issue number: version number shall denote to the
number of version take place. Initial version number shall be 01.

4.1.1.5    
Effective Date: This is the date at which STP
become effective.

4.1.1.6    
Footer Information



4.1.1.7    
File name of STP is given in
the left side and page no. shall be on the right side in the footer.

4.1.1.8    
In the centre following
information shall be given:

COMPANY CONFIDENTIAL

Uncontrolled Copy if CQA
Stamp is not Red

4.1.2     
Top information

4.1.2.1    
Following procedure shall be
followed for STP of Raw and Packing materials.

4.1.2.2    
There shall be RAW MATERIAL/
PACKING MATERIALS SPECIFICATION AND TEST METHOD in centre alignment.

4.1.2.3    
TITLE: The title of STP shall be written in
capital letters.

4.1.2.3.1   
OWNER (S): The HOD of the department where
document is applicable.

4.1.2.4    
Following procedure shall be
followed for STP of Intermediates and finished product.

4.1.2.4.1   
CONTROL MONOGRAM shall be written in centre
alignment

4.1.2.4.2   
TITLE: The title of STP shall be written in
capital letters.

4.1.2.4.3   
GENERIC NAME: The generic name of product shall
written in capital letters.

4.1.2.4.4   
PRODUCT CODE: The code of product shall be
written in capital letters.

4.1.2.4.5   
SHELF LIFE: The shelf life of product shall be
written in capital letters.

4.1.2.4.6   
OWNER (S) : Designation of the HOD where document
is applicable shall be written in capital letters.

4.1.3     
Middle information :

4.1.3.1    
DOCUMENT APPROVAL: A table
shall define the approval details of document as following.

4.1.3.1.1   
Authority : For each specification
and test method there shall be three stage


4.1.3.1.2   
Name: This field of STP implies
name of respective persons of Author, Process owner,  Approver.


4.1.3.1.3   
Job Title: This field of STP
implies for Job designation of respective persons of Author, Process owner, Approver.


4.1.3.1.4   
Signature: This field for
signature of aforesaid persons.


4.1.3.1.5   
Date: Date of sign by aforesaid
persons.


4.1.3.2    
DOCUMENT DISTRIBUTION: This
field gives the detail of offices where STP shall be distributed.

Author : Writer of
specification and test method

Process Owner: The
process owner can be Head of Department or any other senior person, Who can
check the specification and test method.

                Approver: Approver shall be head of Quality Assurance/Corporate
Quality Assurance.

4.1.4     
  Bottom information:

4.1.4.1    
CROSS REFERENCE: This field
gives the code number with issue number of specification and test methods /SOP
which required during the implementation of this specification and test method.

4.2         
SECOND and OTHER PAGES OF STP

4.2.1     
The header information in
second page and on ward shall be same as first page except company address.

4.2.2     
Write the title of STP in place
of company address.

4.2.3     
Footer information shall be
identical to first page.

4.2.4     
CONTENTS: This field of
specification and test method shall give the details of contents with the page
number. Content numbering shall be start from 0.0, 1.0 …….

4.2.5     
VERSION CONTROL HISTORY: This
field gives details of version control, in the form of table such as:

Date

Issue No.

CCR

Change
description/reason/supersedes

4.3         
general information

4.3.1     
At this page of specification
and test method general information about the material lshall be provided but
not limited.

S. No.

Description

Remarks

1

Name

2

Item code

3

Manufacturer

4

Supplier

5

Sampling Reference

6

Storage Condition

7

Maximum period of storage before
retesting

4.3.2     
This field of STP not
applicable for intermediates and finished products.

4.4         
STANDARDS

4.4.1     
This field of STP shall
describe percentage limit of active ingredient in product.

4.4.2      This field of STP shall not applicable for raw and packing
materials.

4.5         
COMPOSITION

4.5.1     
This part of STP shall be in
tabular form in four columns and rows as required as follows.

CODE

INGREDIENT

MG/TABLETS

PERCENT

CODE: It is the code
number of raw material used in product.

INGREDIENT: Name of
raw materials used in product.

MG/ TABLET: It is
amount of raw material per tablet of product.

PERCENTAGE: It is
percentage of raw material per tablets of product.

4.5.2     
This field of STP shall not be
applicable for raw material and packing material.

4.6         
LABEL CLAIM

4.6.1     
This field of STP shall contain
amount of active ingredients.

4.6.2     
This field of STP shall contain
name of color used in product.

4.6.3     
This field of STP shall not be
applicable for raw and packing material.

4.7         
specifications

This part of
specification and test method shall be prepared in table form in three columns
and rows as required.

S.N

TESTS

SPECIFICATIONS

4.7.1     
S.No : Serial number on row
wise.

·        
TESTS : Applicable test to be described.

·        
SPECIFICATION: specification in house or
pharmacoepial

4.8         
Test method

4.8.1     
This part of specification and
test method shall give the details of test method for each test parameters.

4.8.2     
In case of material belong to
official monograph the test method shall be conducted as per monograph.

4.8.3     
In house test method shall
conduct as per defined procedure.

4.9       
 CONTROL OF STP

4.9.1     
All approved STP shall bear
original signature in black ink on the first page with date.

Each page of the STP
shall be stamped with MASTER COPY stamp in RED at the centre of the Header. The
stamp shall have text as “MASTER COPY” in the centre of the first row and space
for initials of the Process Owner written as Owner and Technical Approver written as Approver.

Owner :  Owner shall be the department head / author

Approver : Approver
shall be the Head of Quality.

The facsimile of the
Master Copy stamp is shown below:

This system of Master Copy shall authenticate all the pages of a
SOP.

4.9.2     
After approval of STP, QA
department shall photocopy the STP for the number of copies as mentioned in
‘Copy Distribution’ on first page of the STP.

4.9.3     
The round rubber stamp “CONTROLLED
COPY, ABC Pharmaceuticals., STAMPED IN RED” shall be stamped on the CENTER of
the footer on each page of photocopied STP for distribution. The stamp shall
also have the text ‘Copy No. _____’ which shall be written as per the copy no.
of copy holder at the time of distribution. The facsimile of the stamp is shown
below:

4.9.4     
Quality Assurance department
shall control the issuance & retrieval of all STPs. The details of issuance
& retrieval shall be maintained on AP/QA-0011/FR-01 STP Issuance and
Retrieval Register (Appendix I).        

4.9.5     
The Master Copy shall be
retained with the Head of Quality.

4.10      preparation,
ISSUE, RETRIEVAL AND REVIEW OF STP

4.10.1  
The owner departments shall
prepare all the new & revised STPs. All new or revised STPs, shall be
circulated for the approval. All the concerned personnel shall make their
signature & date in the appropriate columns.    

4.10.2  
After approval of STP, stamp
the STP as ‘Master copy’ and shall be photocopied for distribution as per ‘Copy
Holder’ and shall be stamped as ‘Controlled Copy’ in red and write the ‘Copy
No’ as written in the document distribution on first page of the concerned STP.

4.10.3  
The controlled copy shall be
issued on the effective date of the respective STPs and at the same time
controlled copy (ies) of the superseded STP shall be retrieved and destroyed
immediately by the concerned QA personnel.



4.10.4  
The distribution of STPs shall
be recorded on AP/QA-0011/FR-01 STP Issuance and Retrieval Register
(Appendix-II).

4.10.5  
The master copy of superseded
SOP shall be stamped as “SUPERSEDED” in red on middle of each page of SOP and
preserved for minimum five years from the effective date of the next version.

4.10.6  
If the existing STP shall not
be further used, the master copy shall be stamped as “OBSELETE” in red on
middle of each page of STP and shall be retained forever.

4.10.7  
STP shall be revised if any
change required in the STP.

4.10.8  
A change control shall be
raised if there is any change, for a revision of STP.

APPENDIX
II

Spec. and Test Method No. :

Title    :           ____________________________________

Date of Issue

Issue No.

No. of Copies

Department

Received By / Date

Retrieved By / Date

Destroyed By / Date



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