SOP OF SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA AS PER ICH Q6 A GUIDELINE
Question – 1: The objective of the ICH Q6 A Guideline?
- ICH Q6 A Guideline is intended to assist in the establishment of a single set of global specifications for new drug substances and new drug products.
- Also assisting on the setting and justification of acceptance criteria and the selection of test procedures for new drug substances of synthetic chemical origin, and new drug products produced from them.
- The specifications have not been registered previously in the United States, the European Union, or Japan.
Question – 2: What is the specification?
- 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 tests described.
- It establishes the set of criteria to which a drug substance or drug product should conform to be considered acceptable for its intended use.
- Specifications are one part of a total control strategy for the drug substance and drug product designed to ensure product quality and consistency.
- Also, control strategy includes thorough product characterization during development, upon which specifications are based, and adherence to Good Manufacturing Practices; e.g., suitable facilities, a validated manufacturing process, validated test procedure, raw material testing, in-process testing, stability testing, etc.
- Specifications should focus on those characteristics found to be useful in ensuring the safety and efficacy of the drug
substance and drug product
Question – 3: What is the Conformance to specifications?
Conformance to specifications means that the drug substance and/or drug product, when tested according to the listed analytical procedures, will meet the listed acceptance criteria.
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Alice is the Author and founder of pharmaceutical guidance, she is a pharmaceutical professional having more than 18 years of rich experience in pharmaceutical field.
During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, and Nectar life Science Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube