SOP Title:- Preparation of Specifications , Standard Testing Procedures and General Testing Procedures
1. Objective:
To lay down the procedure for Preparation of Specifications, Standard Testing Procedures, General Testing Procedures for Raw Materials, Packing Materials, Miscellaneous Material, Semi-Finished Products, Finished Products and Stability Products.
2. Scope:
This SOP is applicable for Preparation of Specifications, Standard Testing Procedures, General Testing Procedures for Raw Materials, Packing Materials, Miscellaneous Material, Semi-Finished Products, Finished Products and Stability Products in Quality Control Department .
3. Responsibility:
3.1 Quality Control Department: To prepare and review the SOP. To follow the procedures laid down for Preparation of Specification and Standard Testing Procedure for Raw Materials, Packing Materials and Finished Products in Quality Control Department as per this SOP.
3.2 Quality Assurance Department: To review and approve the SOP and Annexures.
4. Accountability:
Head Quality Control Department, Head Quality Assurance Department.
5. Procedure:
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Sr. No. |
Procedure |
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5.1 |
Specifications are to be Prepared as per below Steps: |
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5.1.1 |
All Raw Materials, Packing Materials, Miscellaneous Material, Semi-Finished Products, Finished Products and Stability Products specifications are prepared as per IP, BP, USP and EP respective Pharmacopoeias or not referred by any Pharmacopoeial monograph then In-house specification to be prepared. |
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5.1.2 |
Additional parameters for Raw Materials like particle size, bulk or tapped density, sieve test etc. to be prepared after successful data generation from last three consecutive batches of respective received materials. |
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5.1.3 |
If Raw Material is not referred by any Pharmacopoeial monograph; In-House specification should be prepared. |
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5.1.4 |
Generate data based on last three consecutive batches of Raw Material as per manufacturer’s specification. |
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5.1.5 |
Additional physical parameters for Finished Products, like length, width, thickness, etc. to be prepared from last three consecutive product validation batches. |
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5.1.6 |
If Finished Product is not referred by any Pharmacopoeial monograph; specification should be prepared as per minimum requirement of Drugs & Cosmetic Act. |
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5.1.7 |
Generate data based on last three consecutive batches of Finished Products. |
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5.1.8 |
All Parameters are prepared based on domestic and export requirements. |
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5.1.9 |
For domestic market as per Indian Pharmacopoeia and for Export consignment as per respective export requirement. |
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5.1.10 |
All Specification shall be numbered as per respective codes mentioned below. |
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5.1.11 |
Raw Material Specification: RM/SPC/XX/NNN/RN Where RM: Raw Material SPC: Stands for specification XX : Denotes the Pharmacopoeia name (IP, BP, USP, EP,IHS) whom Material complies NNN: Denotes the three digits serial number (001, 002, 003….) RN : Represents two digit revision number (00,01,02,03….) |
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5.1.12 |
Packing Material Specification: PM/SPC/XX/NNN/RN
Where PM: Packing Material SPC: Stands for specification XX : Denotes the Pharmacopoeia name (IP, BP, USP, EP,IHS) whom Material complies NNN: Denotes the three digits serial number (001, 002, 003….) RN : Represents two digit revision number (00,01,02,03….) |
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5.1.13 |
Semi-Finished Specification in case of granules/bulk, filled Capsule, Compressed/uncoated and coated tablets : SF/SPC/NNN/RN Where SF : Semi – Finished SPC: Stands for specification NNN: Denotes the three digits serial number (001, 002, 003…) RN : Represents two digit revision number (00,01,02,03….) |
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5.1.14 |
Finished Product Specification :FP/SPC/NNN/RN
Where FP : Finished Product SPC: Stands for specification NNN: Denotes the three digits serial number (001, 002, 003…) RN : Represents two digit revision number (00,01,02,03….)
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5.1.15 |
Refer Annexure No. 04 for preparation of Finished Product Specifications. |
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5.1.16 |
Miscellaneous Material Specification :MM/SPC/NNN/RN
Where MM : Miscellaneous Material SPC: Stands for specification NNN: Denotes the three digits serial number (001, 002, 003…) RN : Represents two digit revision number (00,01,02,03….) |
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5.1.17 |
Stability Study Specification :SS/SPC/NNN/RN Where SS : Stability Study SPC: Stands for specification NNN: Denotes the three digits serial number (001, 002, 003…) RN : Represents two digit revision number (00,01,02,03….) |
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5.2 |
Standard Testing Procedures should be prepared as per below steps: |
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5.2.1 |
1. Standard Test Procedures are prepared for Raw Materials, Packing Materials, Semi-Finished Products and Finished Products as per Pharmacopeia requirement. |
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5.2.2 |
If the Raw Materials, Packing Material, Miscellaneous Material, Semi-Finished Product and Finished Products are not specified in any Pharmacopoeia then Standard Test Procedure is prepared as per in-House specifications. |
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5.2.3 |
Raw Material Standard testing Procedure : RM/STP/XX/NNN/RN Where RM: Raw Material STP: Stands for Standard Testing Procedure XX : Denotes the Pharmacopoeia name (IP, BP, USP, EP,IHS) whom Material complies NNN: Denotes the three digits serial number (001, 002, 003….) RN : Represents two digit revision number (00,01,02,03….) |
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5.2.4 |
Packing Material Standard testing Procedure : PM/STP/XX/NNN/RN Where PM: Packing Material STP: Stands for Standard Testing Procedure XX : Denotes the Pharmacopoeia name (IP, BP, USP, EP,IHS) whom Material complies NNN: Denotes the three digits serial number (001, 002, 003….) RN : Represents two digit revision number (00,01,02,03….) |
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5.2.5 |
Semi-Finished Standard testing Procedure in case of granules/bulk, filled Capsule, Compressed/uncoated and coated tablets :SF/STP/XX/NNN/RN Where SF : Semi-Finished Material STP: Stands for Standard Testing Procedure XX : Denotes the Pharmacopoeia name (IP, BP, USP, EP,IHS) whom Material complies NNN: Denotes the three digits serial number (001, 002, 003….) RN : Represents two digit revision number (00,01,02,03….) |
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5.2.6 |
Finished Product Standard testing Procedure :FP/STP/XX/NNN/RN Where FP : Finished Product STP: Stands for Standard Testing Procedure XX : Denotes the Pharmacopoeia name (IP, BP, USP, EP,IHS) whom Material complies NNN: Denotes the three digits serial number (001, 002, 003….) RN : Represents two digit revision number (00,01,02,03….) |
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5.2.7 |
Miscellaneous Product Standard testing Procedure :MM/STP/XX/NNN/RN Where MM : Miscellaneous STP: Stands for Standard Testing Procedure XX : Denotes the Pharmacopoeia name (IP, BP, USP, EP,IHS) whom Material complies NNN: Denotes the three digits serial number (001, 002, 003….) RN : Represents two digit revision number (00,01,02,03….) |
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5.3 |
General Testing Procedures should be prepared as per below steps: |
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5.3.1 |
Numbering system for General Testing Procedures: GM/GTP/XX-YYY Where GM: General Method GTP: General Testing Procedure XX : Denotes the Pharmacopoeia name (IP, BP, USP, EP,IHS) whom Material complies YYY: Denotes the three digits serial number (001, 002, 003….) |
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6. Definitions / Abbreviations:
6.1 Abbreviations :
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Abbreviation |
Expansion |
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GMP |
Good Manufacturing Practice |
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IHS |
In-House Specification |
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IP |
Indian Pharmacopoeia |
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BP |
British Pharmacopoeia |
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GM |
General Method |
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USP |
United States Pharmacopoeia |
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GTP |
General Testing Procedure |
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EP |
European Pharmacopoeia |
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FP |
Finished Product |
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RM |
Raw Material |
*Note – Ready to use SOP available in “DOWNLOAD” Section.