SOP The Preparation and Issuance of Specification and Test method

SOP on The Preparation and Issuance of Specification and Test method

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:

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.

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.

4.1.1.3.2Packing 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.

4.1.1.3.3Intermediate 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 STPlike 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:

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:

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.

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: 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.

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.

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:

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.

STP ISSUANCE AND RETRIEVAL REGISTER