To lay down the procedure for the Preparation, Approval, Authorization, Control, and Revision of Standard Specification for Raw Materials (RM), In-Process Material (IP), Finish Products (FP), and Packaging Materials (PM).
2.0 SCOPE
This SOP shall apply to all Pharmacopoeial and Non-Pharmacopoeial Specifications of RM, IP, FP, and PM.
3.0 RESPONSIBILITY
3.1 Microbiologist responsible for preparation of this SOP.
3.2 Chemist and above designee shall be responsible for the execution of this SOP.
3.3 Manager QC and Manager QA shall be responsible for checking and approval this SOP.
3.4 HOD Operation shall be responsible for the authorization of this SOP.
4.0 ACCOUNTABILITY
Head Quality Control Department
5.0 PROCEDURE
5.1 QC chemist and above shall prepare the Standard specification for the raw material, In-Process material, packing material, and finished goods.
5.2 Head QC and QA shall review and approve the Standard Specifications.
5.3 After approval and authorization by the Head the control copy of the specification from the QA department shall be issued to QCD.
5.4 The Standard specification shall be prepared in the approved format on A-4 size paper. Refer to Annexure-I for Raw Material, Annexure-II for In-Process Material, Annexure-III for Finished Products, and Annexure IV for Packaging material.
5.5 The type of font for the contents in Standard Specification shall be ‘Times New Roman and the font size shall be ‘12.’
5.6 All the Standard Specifications shall be written in clear, unambiguous language, easy to understand, and easy to follow.
5.7 Each Specification shall have a unique number. Once the number is allocated to any Specification, the same number shall not be repeated to other Specifications.
5.8 The numbering system for the Raw Materials, In-Process material, Finished Product,s and Packaging Material shall be as under
|
TYPE |
numbering SYSTEM |
||
|
1st character |
2nd character |
Next characters |
|
|
Raw Material |
RM |
- |
Serial No. |
|
In-Process Material |
IP |
- |
Item Code |
|
Finish Product |
FP |
- |
Item Code |
|
Packaging Material |
PM |
- |
Serial No. |
Where,
RM
= Indicates Raw Material
IP =
Indicates In-Process Material
FP = Indicates Finished Product
PM = Indicates Packaging Material
- = Separator
Serial No. =
Starting from 001
Item Code =Batch
Code of the product
5.9 After initiation, approval, and authorization of Standard Specification, the Master copy shall be submitted to QA.
5.10 Any change in Specification shall be done through Change Control Procedure (Refer to the current version of SOP No.:…………….)
5.11 After revision, a Master copy of the Standard Specification shall be submitted to the QA documentation cell for control and issuance.
5.12 Definitions:
5.12.1 Specifications: A specification is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria which are numerical limits, ranges, or other criteria for the test described. It establishes the set of criteria to which a drug substance or drug product should confirm to be considered acceptable for its intended use.
5.12.2 Raw Material: A general term used to denote starting material, reagents, intermediates, process aids, solvents, excipients, and API’s intended for use in the production of drug product or drug substances.
5.12.3 In-Process Material: Any material fabricated, compounded, blended or derived by the chemical reaction that is produced for and used in, the preparation of the drug product.
5.12.4 Finished Product (Drug Product): A medicinal product that has undergone all stages of production, including packaging in its final container intended for marketing.
5.12.5 Packaging Material: Any material intended to protect an intermediate or dosage form during storage and transport.
5.12.6 Change Control: A formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect a validated process status. The intent is to determine the need for action that would ensure that the system is maintained in a validated state.
6.0 REFERENCES
|
SOP No. |
Title
of SOP |
|
………………………….. |
Change Control Procedure |
7.0 ANNEXURE
|
Annexure
No. |
Title
of Annexure |
Format
No. |
|
Annexure-I |
Standard Specification format of RM |
F…………………. |
|
Annexure-II |
Standard Specification format of IP |
F…………………. |
|
Annexure-III |
Standard Specification format of FP |
F…………………. |
|
Annexure-IV |
Standard Specification format of PM |
F…………………. |
8.0 ABBREVIATIONS
SOP: Standard Operating Procedure
No.: Number
Dept. : Department
QA : Quality Assurance
IHS : In House Specification
IP : Indian Pharmacopeia
END OF DOCUMENTS
You may like to read these links:
1. List of All SOPs and Documents for the Microbiology Laboratory
2. List of All SOPs and Documents for In-vitro Laboratory
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