SOP On Preparation, Approval and Control of General Test Procedures
Objective : To lay down a procedure for the preparation, approval and control of General Test Procedures.
Scope : This Standard Operating Procedure is applicable for the preparation and implementation of all General Test Procedures.
Microbiological tests and testing methods for packaging materials (i.e. test methods common to one type of items e.g. carton, label and others) shall be prepared as GTPs.
Responsibility : Scientist, Documentation Cell (R&D) to prepare GTPs and Scientist, Analytical Research and Development to check the GTPs for microbiological assays/ tests.
Scientist, Packaging Development to prepare GTPs for packaging materials and Scientist In-charge or Group Leader, Packaging Development to check the GTPs.
Head, Analytical Research & Development or his/her designee and Head, Quality Control or his/her designee to approve GTPs.
Head, Regulatory Affairs or his/her designee to Approve GTPs.
Head, Quality Assurance or his/her designee shall be responsible for final approval of GTPs.
Abbreviations and Definitions
GTP : General Test Procedure; a controlled document which shall define general test methodologies for testing of materials.
ASTM: American Society for Testing and Materials
APHA :American Public Health Association
Procedure
Preparation and Approval of GTPs
The GTPs shall be prepared referring different pharmacopoeias or other acceptable references including in-house references.
All GTPs shall be written in clear and easy to understand language.
All GTPs shall be printed on one side of standard A-4 size white paper of appropriate quality in black ink.
All GTPs shall be prepared using Microsoft Word application software.
All GTPs shall be generated on computer in the formats given in Annexure-1 and shall be typed in font face ‘Times New Roman’ with font size ‘12’ or with other appropriate font size.
The company logo shall be there on top left hand side of page.
Words ‘General Test Procedure’ shall be typed in bold on the top right hand side of the page (font size 13).
‘Title’ of the GTPs shall be brief and self-descriptive in nature. It shall be typed in regular text keeping the first letter of the key words in capitals (i.e. title case).
‘Reference’ shall be clearly mentioned in this column as pharmacopoeial or In-house or others like IS, ASTM, APHA etc. In case of pharmacopoeial reference mention BP/IP/Ph.Eur./USP/USNF, etc. as applicable and in case of in-house reference write IH or In-house in regular text.
‘Page No.’ shall be numbered, as specific page number of the total pages of GTPs e.g. first page of GTP of total 03 pages shall be 01 of 03.
‘GTP No.’ shall be an alphanumeric number.
GTP Number shall be given as ‘XXX-T’ with Revision Number as ‘Rev No. XX’ where
XXX :shall be a serial number of the GTP (From 001 to 500 for the GTPs of packaging materials and from 501 to 999 for other type of GTPs)
T : denotes Test procedure.
XX : shall be 00 to 99, indicating revisions of GTP
e.g. GTP for cartons (packaging material) shall be written as 012-T Rev.No.00 under ‘GTP No.’ column. Reference of GTPs in STPs and Specifications, whenever required, shall be given by mentioning the GTP number without revision number.
‘Supersedes’: Superseded number of the GTP shall be given in this column. For example, GTP with GTP number 012-T Rev. No.00 when prepared for the first time (first version), ‘Supersedes’ column shall be filled with the word ‘None’ and when the same is revised for the first time, ‘Supersedes’ shall be given as 012-T Rev. No.00 and 012-T Rev. No.01 shall be mentioned under ‘GTP No.’
‘Effective Date’ is the date when the contents of GTPs become operational for the user department(s). It shall be given after approval of proposed GTPs by QA department in DD-MM-YY format, by hand.
The ‘Next Review Date’ shall be two years from the Effective Date of the GTPs, given by QA department in DD-MM-YY format, by hand. Every GTP shall be revised within two months of Next Review Date or earlier, if any amendment is required.
The concerned Scientist and Scientist In-charge or Group Leader shall sign in the column ‘Prepared by’ and ‘Checked by’ respectively.
Head, Analytical Research & Development or his/ her designee, Head Regulatory Affairs or his/her designee and Head, Quality Control or his/ her designee shall sign in the column ‘Approved by’ under R&D,RA and QC heads respectively.
Head, QA or his / her designee shall approve the GTP by signing the same in the column ‘Approved by’ under QA head
Note: Heading entries as described shall be typed in bold with font size of 12. All the entries made in hand by the concerned personnel shall be in black ink. Ink of good quality shall be used for the purpose.
Different steps of GTP shall be typed using outline numbering system.
Review and Control of GTPs
Preparation of Master copies and Controlled copies, distribution and retrieval, review and/ or revision of GTPs shall be undertaken as per SOP titled ‘Document and Data Control’.
All GTPs shall be reviewed biennially i.e. once in two years. QA shall identify the GTPs at least two months before approaching the end of two years from the effective date. QA shall initiate review process as per SOP titled ‘Document and Data Control’.