SOP The preparation and issuance of specification and test method

0.0         
what

1.0         
why

2.0         
when

3.0         
RESPONSIBILITY

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

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

4.1.1.3.2    Packing Materials

4.1.1.3.3    Intermediate and finished products

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:

4.1.2     
Top information

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

4.1.3     
Middle information :

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

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.

4.5         
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

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.

4.7         
specifications

S.N

TESTS

SPECIFICATIONS

4.7.1     
S.No : Serial number on row
wise.

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.

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.

Date of Issue	Issue No.	No. of Copies	Department	Received By / Date	Retrieved By / Date	Destroyed By / Date