SOP for Preparation, Authorization, Revision, and control of specifications, Standard testing procedures, and General test Procedures
PURPOSE: To lay down a standard procedure to describe the steps to be followed and persons involved in the preparation, issuance, revision, and control of Specifications and Standard Testing Procedures.
SCOPE: This procedure applies to the Quality control department. This SOP applies to the following documents
Specification & Standard Testing Procedure for Raw Material.
Specification & General Testing Procedure for Packaging Material Specification.
Specification & Standard Test Specification for Bulk Products, uncoated products, coated product and finished Products.
General Test Procedure.
Attachments
- Raw material specification
- Raw Material Standard Testing Procedure
- Packing material specification
- Packing material General Testing Procedure
- Standard testing Procedure of Finished Product / Bulk Product /Uncoated Product / Coated product
- Bulk product specification
- Uncoated product specification
- Coated product specification
- Finished product specification
- General Testing Procedure
RESPONSIBILITY :XZ
*
QC department person: To prepare Specifications, Standard Testing Procedures & General Testing Procedures for
Raw material, Packaging material, bulk Product, uncoated product, coated produce, and finished Product.
Department Head: To review the document and To ensure implementation of the document.
QA Head: To ensure the implementation of the defined system.
PROCEDURE:
PREPARATION OF STS & STP OF RAW MATERIAL AND PACKING MATERIAL
All Specifications and standard testing procedures must be drafted by the Quality control department and sent a draft copy for comment to concerned people. Make necessary corrections, if suggested. Concerned Department personnel take the final printout and circulate it for taking signatures of responsible staff.
Character type should be Arial and font size should be 11 for all documents otherwise specified for individual. It does not apply to the text mentioned in the attachments.
The header part of the Raw material / Packing material specification must contain the following :
Material Name: Write the name of the material in case of raw material / Packaging material. If the Brand name or Patent Name is available for Raw material then first write the material name, generic or Pharmacopoeial name, and write the brand or patent name in the bracket.
Item code: The item code should be 8 digits for Raw material and packing material. All 8 digits should be numeric for Raw material code.
The packing material code should be 8 digits. ‘AAANNNNN’ First 3 digit should be the alphabet and the last 5 digits should be the numeric value. The first 3 digits should be ‘PMP’ or ‘PMS’.
PMP – Primary packing material, PMS – Secondary packing material.
STS No. – STS No. should be for 16 digit. Example, STS. No. is ‘PP/QC/STS/RR/NNN’.
PP – Denote Plant codes
QC – Denotes Quality Control
STS – Denotes Standard Test Specification.
RR – Denotes category of material like RM for raw material and PM for packing material.
NNN – Denotes Serial No. (i.e. 001, 002, —– n)
STP No. – STP No. should be for 16 digits. STS. No. is ‘PP/QC/STP/RR/NNN’.
PP – Denote Plant code.
QC – Denotes Quality Control
STP – Denotes Standard Test Procedure.
RR – Denotes category of material like RM for raw material and PM for packing material.
NNN – Denotes Serial No. (i.e. 001, 002, —– n)
Retest Period – Retest period is the duration after which a material is to be verified for its quality. The retest period should be written in months. For example, if the retest period is one year it should be written as ’12 months’.
Reference – Reference details are the document from which procedure, specification, etc. has been referred as a requirement.
Version No. – Version no. should be ‘00’ for the new document and shall increase in order after each revision.
Effective Date – The effective date shall be written as DD/MM/YYYY. It is the date on which the document comes into effect.
Review Date – The review date is the date on which the document is to be reviewed. The review period should be ± 1 month of the defined period or date mentioned. The review period is two years for specification and test procedures. But may be revised if changes are required at any time.
Designation – Write the designation of which person prepared, checked, and approved the document.
Prepared By – Which person prepared the document
Checked By – Which person checked the document
Approved By – Which person approved the document.
Name – Write the name of which person who prepared, checked, and approved the document.
Signature – sign off the document, who prepared, checked,d, and approved the document.
Date – It is the date on which the mentioned activity i.e. prepared, checked, and approved the document. The date shall be handwritten and as DD/MM/YYYY.
Footer part of Raw material / Packing material specification must contain the following::
The footer part must contain Page no. on the right corner of the page, in the form of X or Y. Where X is the page number and Y is the total page in the document.
Row level part of Raw material / Packing material specification must contain the following::
All raw material specifications must have the following headings.
S. No. – S. No. shall be in serially and written as a numeric value.
Test – All tests shall be written below the heading of the test.
Specification – Specifications are the limits to be met for particulars. It may be quantitative/qualitative and may contain upper and lower limit / only upper limit / only lower limit.
Retest parameter – Retest parameters are the parameters considered at the time of retesting of raw materials.
All packing material standard test specifications must have the following heading.
S. No. – S. No. shall be in serially and written as a numeric value.
Test – All tests shall be written below the heading of the test.
Specification – Specifications are the limits to be met for particulars. It may be quantitative/qualitative and may contain upper and lower limit / only upper limit / only lower limit.
Ref. GTP No. – Reference GTP No. is the general test procedure to be followed to perform a test.
Direction for sampling – Below all specifications write the direction for sampling and give the reference of sampling SOP or containing specific requirements if any.
Storage condition – Storage condition should be written as per Pharmacopeia or as per in-house
The header part of the Raw material standard test procedure must contain the following :
In the first column of the first row, the Company logo should be present if any otherwise write the company logo.
Material Name: Write the name of the material in case of raw material / Packaging material. If Brand name or Patent Name is available for Raw material then first write the material name, generic or Pharmacopoeial name and write the brand or patent name in the bracket.
Item code: Item code should be for 8 digit for Raw material. All 8 digit should be numeric for Raw material code.
STP No. – STP No. should be for 16 digit. STS. No. is ‘PP/QC/STP/RR/NNN’.
PP – Denote Plant code .
QC – Denotes Quality Control
STP – Denotes Standard Test Procedure.
RR – Denotes Raw material
NNN – Denotes Serial No. (i.e. 001, 002, —– n)
Reference – Reference detail are the document from which procedure, specification etc. has been referred as a requirement.
Version No. – Version no. should be ‘00’ for new document and shall increase in order after each revision.
Effective Date – Effective date shall be written as DD/MM/YYYY. It is the date on which the document come into effect.
Review Date – Review date is the date on which the document to be review. Review period should be ± 1 month of defined period or date mentioned. The review period is two year for standard test procedures. But may be revised if changes are required to any time.
Designation – Write the designation of which person prepared, checked and approved the document.
Prepared By – Which person prepared the document.
Checked By – Which person checked the document.
Approved By – Which person checked the document.
Name – Write the name of which person prepared, checked and approved the document.
Signature – sign off the document, who prepared, checked and approved the document.
Date – It is the date on which the mentioned activity i.e. prepared, checking and approval of document. Date shall be hand written and as DD/MM/YYYY.
Footer part of Raw material Standard test procedure must contain the following ::
Footer part must be contain Page no. on the right corner of the page, in the form of X of Y. Where X is the page number and Y is the total page in the document.
Row level part of Raw material Standard test procedure must contain the following
All raw material standard test procedure must have following headings.
Procedure for Analysis: Procedure for analysis contained detailed procedure for analysis according to test wise
Attachments: All attachment related to document shall be under of headings attachment.
PREPARATION OF STS OF BULK PRODUCT, UNCOATED TABLET, COATED TABLET AND FINISHED PRODUCT & STP OF FINISHED PRODUCT.
All Specifications and standard testing procedures must be drafted by Quality control department and send draft copy for comment to concerned people. Make necessary corrections, if suggested. Concerned Department personnel take final print out and circulate for taking signatures of responsible staff.
Header part of Bulk, uncoated, coated, and finished Product specification must contain the following :
In first column of first row, Company logo should be present if any otherwise write the company logo.
Product Name: Write the name of Product / Brand Name
Generic name: Chemically name of the drug.
STS No. – STS No. should be for 16 digit. STS. No. is ‘PP/QC/STS/RR/NNN’.
Denote Plant code .
QC – Denotes Quality Control
STS – Denotes Standard Test Specification.
RR – Denotes (BP for Bulk Product, UT for uncoated product, CT for coated product, FP for finished product)
NNN – Denotes Serial No. (i.e. 001, 002, —– n)
Version No. – Version no. should be ‘00’ for new document and shall increase in order after each revision.
Effective Date – Effective date shall be written as DD/MM/YYYY. It is the date on which the document come into effect.
Review Date – Review date is the date on which the document to be review. Review period should be ± 1 month of defined period or date mentioned. The review period is two year for specification and test procedures. But may be revised if changes are required to any time.
Designation – Write the designation of which person prepared, checked and approved the document.
Prepared By – Which person prepared the document.
Checked By – Which person checked the document.
Approved By – Which person checked the document.
Name – Write the name of which person prepared, checked and approved the document.
Signature – sign off the document, who prepared, checked and approved the document.
Date – It is the date on which the mentioned activity i.e. prepared, checking and approval of document. Date shall be hand written and as DD/MM/YYYY.
Footer part of Bulk, uncoated, coated and finished product specification must contain the following:
Footer part must be contain Page no. on the right corner of the page, in the form of X of Y. Where X is the page number and Y is the total page in the document.
Row level part of Bulk, uncoated, coated and finished product specification must contain the following:
All Bulk, Uncoated, Coated and Finished Product specification must have following headings.
S. No. – S. No. shall be in serially and written as a numeric value.
Test – All test shall be written below the heading of test.
Standard Specification – Standard Specification are the limits to be meet for a particulars. It may quantitative / qualitative and may contain upper and lower limit / only upper limit / only lower limit.
Release Specification – Release Specification are the narrow limits to be decide by in house and meet for a particulars. It may quantitative / qualitative and may contain upper and lower limit / only upper limit / only lower limit.
The header part of the finished product standard test procedure must contain the following
In first column of first row, Company logo should be present if any otherwise write the company logo.
In second column of first row, write company name with proper address. Company name and address should be written in Capital letter. Font size should be 12 for company name and 10 for company address.
Product Name: Write the name of Product / Brand Name
Generic name: Chemically name of the drug.
STP No. – STS No. should be for 16 digit. STS. No. is ‘PP/QC/STP/FP/NNN’.
PP – Denote Plant code.
QC – Denotes Quality Control
STP – Denotes Standard Test Procedure.
FP – Denotes the finished product
NNN – Denotes Serial No. (i.e. 001, 002, —– n)
Version No. – Version no. should be ‘00’ for new document and shall increase in order after each revision.
Effective Date – Effective date shall be written as DD/MM/YYYY. It is the date on which the document come into effect.
Review Date – Review date is the date on which the document to be review. Review period should be ± 1 month of defined period or date mentioned. The review period is two year for specification and test procedures. But may be revised if changes are required to any time.
Designation – Write the designation of which person prepared, checked and approved the document.
Prepared By – Which person prepared the document.
Checked By – Which person checked the document.
Approved By – Which person checked the document.
Name – Write the name of which person prepared, checked and approved the document.
Signature – sign off the document, who prepared, checked and approved the document.
Date – It is the date on which the mentioned activity i.e. prepared, checking and approval of document. Date shall be hand written and as DD/MM/YYYY.
Footer part of finished product Standard test procedure must contain the following
Footer part must be contain Page no. on the right corner of the page, in the form of X of Y. Where X is the page number and Y is the total page in the document.
Row level part of finished product Standard test procedure must contain the following
All finished product standard test procedure must have following headings.
Composition: A composition is the amount of drug in a particular dose.
Procedure for Analysis: Detailed procedure for analysis
Attachments: Detail of attachments / Annexure
