To lay down the procedure for preparation of Specifications, Standard Testing Procedures (STPs), General Test Procedures (GTPs) and Certificate of Analysis (COA).
1.0 PURPOSE
1.1 To lay down the procedure for preparation of Specifications, Standard Testing Procedures (STPs), General Test Procedures (GTPs) and Certificate of Analysis (COA).
2.0 SCOPE
2.1 This procedure is applicable to all Quality Assurance & Quality Control units.
3.0 RESPONSIBILITY
3.1 Quality Control (QC) for preparation and checking.
3.2 Quality Assurance (QA) for checking and approval.
3.3 Head-Production for checking (Specification only)
4.0 ACCOUNTABILITY
4.1 Manager-Quality Assurance & Regulatory Affairs
5.0 PROCEDURE
5.1 Quality Control shall prepare the document as per the following specimen formats
5.1.1 Standard Testing Procedure -Annexure-I.
5.1.2 General Testing Procedure-Annexure-II.
5.1.3 Specification (Raw Material)-Annexure-III.
5.1.4 Specification (Packing Material)-Annexure-IV.
5.1.5 Specification (Inprocess)-Annexure-V.
5.1.6 Specification (Intermediate)-Annexure-VI.
5.1.7 Specification (Active Pharmaceutical Ingredient/ Drug Product)-Annexure-VII.
5.1.8 Certificate of Analysis- Annexure - VIII.
5.2 All the characters in the above mentioned documents Header, Footer and text matter shall be taken in “Times New Roman” with font size of “12”.
5.3 Specification Format
5.3.1 The Specification format for Raw Material/Packing Material/ Inprocess/ Intermediate/Active Pharmaceutical Ingredient Consists of the following information in the respective cells of the specimen format as given in Annexure-VII)
|
Cell Number |
Information |
Font |
|---|---|---|
|
01 |
Name of the Raw Material / Packing Material / Inprocess / intermediate/API as applicable including the standard e.g. In-house, USP, EP etc. |
Sentence case |
|
02 |
To write the product code |
Upper case & numerals |
|
03 |
To write the specifications number as per section no 5.6. |
Alphanumerical |
|
04 |
Page X of Y [X is the page number and Y is the total number of page] |
Sentence Case |
|
05 |
To write the date from which the specification will be implemented
|
dd/mm/yyyy |
|
06 |
To write the review date which is 2 years from the effective date |
dd/mm/yyyy
|
5.3.2 Regulatory specification shall be derived based on
5.3.2.1 Pharmacopoeia
5.3.2.2 Accelerated stability study of non pharmacopoeia products
5.3.2.3 Annual product review
5.3.3 The Content (text matter) of the specification consists of the following
5.3.3.1 REVISION SUMMARY
5.3.3.1.1 It details the history of Specification i.e. the changes undergone since first issue of the Specification in ascending order.
5.3.3.2 PRODUCT INFORMATION: Write the details about respective product as mentioned in respective format as given in Annexure-III to Annexure-VII.
5.3.3.3 SPECIFICATION: Write the respective test and specification in respective column of format as given in Annexure-III to Annexure-VII.
5.3.3.4 The subheading to be taken in the format are indicated in the respective format as given in Annexure-III to Annexure-VII.
5.4 STP Format
5.4.1 The STP format consists of the following information in the respective cells of the format as given in Annexure-I.
|
Cell Number
|
Information |
Font |
|---|---|---|
|
01 |
To write the name of the product include the standard e.g. In-house, USP, EP etc. |
Sentence case |
|
02 |
To write the product code |
Upper case & numerals |
|
03 |
To write the STP number as per the section 5.6 |
Upper case & numerals |
|
04 |
Page X of Y [X is the page number and Y is the total number of page] |
Sentence Case |
|
05 |
To write the date from which the STP will be implemented |
dd/mm/yyyy |
|
06 |
To write the next review date, which is 2 years from the effective date |
dd/mm/yyyy |
Cell
Number
Information Font
01 To write the name of the product include the standard e.g. In-house, USP, EP etc. Sentence case
02 To write the product code Upper case & numerals
03 To write the STP number as per the section 5.6 Upper case & numerals
04 Page X of Y [X is the page number and Y is the total number of page] Sentence Case
05 To write the date from which the STP will be implemented dd/mm/yyyy
06 To write the next review date, which is 2 years from the effective date dd/mm/yyyy
5.4.2 The Content (text matter) of the STP consists of the following:
5.4.2.1 REVISION SUMMARY:
5.4.2.1.1 It details the history of STP i.e. the changes undergone since first issue of the STP in ascending order.
5.4.2.2 STP shall be prepared from the test method given by analytical R & D or from pharmacopoeia.
5.4.2.3 STP shall provide the method of the tests as per the respective specification.
5.4.2.4 For all test parameters, following points should be covered.
a) Name of the Test
b) Reference of General test procedure (If any).
c) Apparatus used.
d) List of Reagents.
e) Procedure.
5.4.3 All subheadings of the STP shall be taken in bold letters.
5.5 GTP Format
|
Cell Number |
Information |
Font |
|---|---|---|
|
01 |
To write the Title of the test |
Sentence case |
|
02 |
To write the GTP number as per the section 5.7 |
Upper case & numerals |
|
03 |
Page X of Y [X is the page number and Y is the total number of page] |
Sentence Case |
|
04 |
To write the date from which the GTP will be implemented |
dd/mm/yyyy |
|
05 |
To write the next review date, which is 2 years from the effective date |
dd/mm/yyyy |
5.5.2 The Content (text matter) of the GTP consists of the following
5.5.2.1 REVISION SUMMARY:
5.5.2.1.1 It details the history of GTP i.e. the changes undergone since first issue of the GTP in ascending order.
5.5.2.1.2 All subheadings of the GTP shall be taken in bold upper case letters.
5.5.2.1.3 For all test parameters, following points should be covered.
a) Apparatus used.
b) List of Reagents.
c) Procedure.
d) Reference (If any)
5.6 STP / Specification Numbering
5.6.1 All STP/Specification shall have a unique number consisting of thirteen characters of alphanumeric system as described below:
Typical example 1: SRM0011301-00 indicates specification for Activated carbon.
5.6.2 Type of Document
|
S. No |
Material |
Code |
|
01 |
Specification |
S |
|
02 |
Standard Test Procedure |
T |
|
03 |
Analytical test Protocol |
P |
5.6.3 Product Code
Product codes shall be given for all materials as per material code.
5.6.4 Type of standard
For different type of standard give number starting from 01.
5.6.5 Version number
The version number shall be given in continuation as follows
|
S. No |
Version |
Number |
|
01 |
First version |
01 |
|
02 |
Second version |
02 |
|
03 |
Third version |
03 |
5.6.6 A number given to the STP/ Specification will not change and cannot be assigned to a new STP/Specification in case that particular document is discontinued.
5.7 GTP Numbering
5.7.1 All GTP shall have a unique number consisting of nine characters of alphanumeric system as described below:
5.8 Certificate of Analysis (COA) Format
5.8.1 The COA format consists of the following information in the respective cells of the specimen format as given in Annexure-VIII.
|
Cell Number |
Information |
Font |
|---|---|---|
|
1 |
To write the Product Name including the standard e.g. In-house, USP, EP etc. |
Sentence case |
|
2 |
To write the Batch Number |
Upper case & numerals |
|
3 |
To write the Manufacturing Date |
mm/yyyy |
|
4 |
To write the quantity of material to be released. |
Numerals |
|
5 |
Page X of Y [X is the page number and Y is the total number of page] |
Sentence Case |
|
6 |
To write the A.R number of the Product |
Alphanumeric |
|
7 |
To write the Date of Release
|
dd/mm/yyyy |
|
8 |
To write the Expiry Date/Retest Date |
mm/yyyy |
5.8.2 The Content (text matter) of the COA consists of the following
5.8.2.1 Write the respective test and Specification along with results in respective column as given in Annexure - VIII.
5.8.2.2 REMARKS: Write the remarks “ The Material complies/Does not complies as per above specification No ……………..”.
5.8.3 Out going certificate of analysis shall be taken on directly complete letter head as per Annexure-XI
5.9 Document approval:
5.9.1 Three sets of original prints of every individual document shall be made. Each set shall be signed as below:
5.9.2 The person who writes the document shall sign on “PREPARED BY” column along with date.
5.9.3 Head-QC or his deputy shall sign the first part of CHECKED BY after checking the document, sign along with date.
5.9.4 QA Representative shall sign in the second part of “CHECKED BY” column along with date.
5.9.5 Manager-QA shall finally approve with sign in the “APPROVED BY” column with date.
5.10 Distribution of documents.
5.9.1 Three original prints of an STP /GTP/Specification shall be distributed as under
5.9.1.1 First copy as Documentation Cell Copy shall be archived in QA department.
5.9.1.2 Second copy, as the Concern Department Head Copy shall be archived in the Quality Control department.
5.9.1.3 Third copy as display or reference copy.
5.9.2 Any further copy required shall be photocopied from the Documentation cell copy and stamped as “CONTROLLED COPY “ in blue ink on bottom corner towards right hand side on all pages with an initial of QA representative along with the copy number and date.
5.9.3 When STP/GTP/Specification is required to distribute outside the premises and out of the company’s control, take photocopy of the “Documentation cell copy” of that particular SOP and stamp as “UNCONTROLLED COPY NOT FOR OPERATIONAL USE” in red ink over the printed matter.
5.9.4 QA representative shall record the distribution details in Document Distribution/Retrieval record for each document with an index (Annexure-IX). This record shall be attached with the documentation cell documents.
5.9.5 An index with a current version number of all documents (STP/GTP/Specification) shall be prepared as per the format given in Annexure X. The current index shall be filed with the Document Cell and User Department.
5.11 Revision of STP/GTP/Specifications.
5.10.1 STP/GTP/Specification shall be revised or discontinued as per the change control procedure (SOP Preparation, Review, Approval, Distribution And Revision Of Standard Operating Procedure of current version).
5.10.2 QA representative shall ensure the retrieval of distributed copies except uncontrolled copies prior to issue of revised document.
5.10.3 QA should ensure the retrieval of all the copies and destroy except “Documentation cell copy”.
5.10.4 “Documentation Cell copy” of previous version shall be stamped as OBSOLETE FOR REFERENCE ONLY in red colour and archived in QA department in a separate file.
END OF DOCUMENT
Preparation, certificate of analysis, general test procedure, quality assurance
