Q&A ON VALIDATION OF ANALYTICAL PROCEDURES – ICH Q2 GUIDELINE PART -1 Question 1: What is the objective of validation of an analytical procedure according to the ICH Q2? Answer 1: The objective of validation of an analytical procedure is to demonstrate its suitability for its intended purpose. Question 2: …

Q&A on Pharmaceutical Quality System (PQS) – ICH Q10 guideline Part -10 Question 1: What is the purpose of management review regarding process performance and product quality? Answer 1: The purpose of management review regarding process performance and product quality is to provide assurance that these aspects are managed effectively …

Q&A on Pharmaceutical Quality System (PQS) – ICH Q10 guideline Part -9 Question 1: How should changes be managed in the pharmaceutical development stage? Answer 1: Changes in the pharmaceutical development stage should be an inherent part of the process and documented accordingly. The formality of the change management process …

Q&A on Pharmaceutical Quality System (PQS) – ICH Q10 guideline Part -8 Question 1: What types of actions should be implemented through the CAPA system according to the ICH Q10? Answer 1: The CAPA system should implement corrective actions and preventive actions resulting from the investigation of various issues such …

Q&A on Pharmaceutical Quality System (PQS) – ICH Q10 guideline Part -7 Question 1: Why is it important for pharmaceutical companies to implement a system for monitoring process performance and product quality? Answer 1: It is important for pharmaceutical companies to implement such a system to ensure a state of …

Q&A on Pharmaceutical Quality System (PQS) – ICH Q10 guideline Part -6 Question 1: What are the four elements of the pharmaceutical quality system described in the ICH Q10? Answer 1: The four elements of the pharmaceutical quality system described in the ICH Q10 are: Process performance and product quality …

Q&A on Pharmaceutical Quality System (PQS) – ICH Q10 guideline Part -5 Question 1: What is management responsible for regarding resource management according to the ICH Q10? Answer 1: Management is responsible for determining and providing adequate and appropriate resources (human, financial, materials, facilities, and equipment) to implement and maintain …

Q&A on Pharmaceutical Quality System (PQS) – ICH Q10 guideline Part -4 Question 1: What role does leadership play in ensuring the effectiveness of a pharmaceutical quality system? Answer 1: Leadership is essential for establishing and maintaining a company-wide commitment to quality and for the performance of the pharmaceutical quality …

Q&A on Pharmaceutical Quality System (PQS) – ICH Q10 guideline Part -3 Question 1: Why is it important for the design, organization, and documentation of the pharmaceutical quality system to be well structured and clear? Answer 1: It is important for the design, organization, and documentation of the pharmaceutical quality …

Pharmaceutical Quality System (PQS) – ICH Q10 guideline Part -2 Question 1: What is the primary aim of implementing a system according to the ICH Q10 guideline? Answer 1: The primary aim of implementing a system, is to ensure the delivery of products with quality attributes suitable to meet the …

Pharmaceutical Quality System (PQS) – ICH Q10 guideline Part -1 Question 1: What is the main focus of the Pharmaceutical Quality System (PQS) outlined in the ICH Q10 guideline? Answer 1: The main focus of the Pharmaceutical Quality System (PQS) described in the ICH Q10 guideline is to establish an …

Production and Process Controls Each manufacturer shall develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications. Where deviations from device specifications could occur as a result of the manufacturing process, the manufacturer shall establish and maintain process control procedures that describe any process …

Critical Area – Class 100 (ISO 5) AS PER USFDA GUIDELINE A critical area is one in which the sterilized drug product, containers, and closures are exposed to environmental conditions that must be designed to maintain product sterility (§ 211.42(c)(10)). Activities conducted in such areas include manipulations (e.g., aseptic connections, …

VALIDATION OF ASEPTIC PROCESSING AS PER USFDA GUIDELINE Process Simulations To ensure the sterility of products purporting to be sterile, sterilization, aseptic filling, and closing operations must be adequately validated (§ 211.113). The goal of even the most effective sterilization processes can fail to achieve their objective if the sterilized …

Air Filtration – High-Efficiency Particulate Air (HEPA) As Per USFDA GUIDELINE HEPA filter integrity should be maintained to ensure aseptic conditions. Leak testing should be performed at installation to detect integrity breaches around the sealing gaskets, through the frames, or at various points on the filter media. Thereafter, leak tests …

Air Filtration by Membrane AS PER USFDA GUIDELINE Air Filtration by Membrane – A compressed gas should pass for purity test to ensure it is free from oil and meets the required standards for microbiological and particle quality after filter. The quality of the compressed gas should be at least …

Alcoa++ In a world where data plays a crucial role in decision-making and technological advancements shape various industries, the significance of data integrity cannot be emphasized enough. Alcoa, a company renowned for its commitment to excellence, extends the principles of Alcoa Plus Plus beyond aluminum production to prioritize data integrity …

CIP -Cleaning In Place  CIP, also known as Cleaning In Place, is a methodical and automated technique used to clean the inner surfaces of manufacturing equipment, including tanks, pipes, and vessels, without the need for disassembly. This approach is extensively utilized in the pharmaceutical sector to remove any remnants of …

Intervention during Media fill Media fill is a simulation exercise conducted in aseptic processing areas to evaluate the capability of operators and the manufacturing environment to maintain sterility. The process involves filling sterile growth media into containers using the same equipment and procedures employed in the actual drug manufacturing. It …

Methods of sterilization Sterilization is necessary for the complete destruction or removal of all microorganisms (including spore-forming and non-spore forming bacteria, viruses, fungi, and protozoa) that could contaminate pharmaceuticals or other materials and thereby constitute a health hazard. Since the achievement of the absolute state of sterility cannot be demonstrated, …