Pharmaceutical companies and regulatory agencies work together to enhance patient safety when a medicine is first being studied (pre-approval) and after it becomes available to patients and their health care providers as a treatment option, following authorization by regulatory agencies (post-approval). Regulatory agencies are government or non-government authorities, responsible for oversight of the effectiveness, safety, […]
1.0 Overview A Standard Operating Procedure (SOP) is a set of written instructions that document a routine or repetitive activity followed by an organization. The development and use of SOPs are an integral part of a successful quality system as it provides individuals with the information to perform a job properly, and facilitates consistency in […]
Change control is defined as : “A formal system by which qualified representatives of appropriate disciplines review propose or actual changes that might affect a validated status. The intent is to determine the need for action that would ensure and document that the system is maintained in a validated state.” The implementation of a change […]
The F0 value of a saturated steam sterilisation process is the lethality expressed in terms of the equivalent time in minutes at a temperature of 121 °C delivered by the process to the product in its final container with reference to micro-organisms possessing a Z-value of 10. The total F0 of a process takes […]
The success of sterilization is dependent upon the performance reliability of the autoclave. Validation of effectiveness includes monitoring temperature, pressure and cycle duration time for each cycle and providing periodic sterilization/decontamination challenges (quality assurance), i.e. use of biological indicators. A logbook should be maintained to record autoclave use and be available for inspection. Temperature: This […]
Content may include the following descriptions (but not be limited to): 1. Introduction1.1 Project Description1.2 What a Validation Master Plan Is1.3 Scope of Validation Master Plan1.4 Definition for the Term Validation1.5 Validation Team Member1.6 Validation Team Responsibility 2. Concept of Qualification or Validation2.1 Fundamentals2.2 Concept of a Validation Life Cycle2.3 Elements of Validation2.4 Documentation Format […]
1. Definition of Validation Action of proving, in accordance with the principles of good manufacturing practice, that any procedure, process, equipment, material, activity, or system actually leads to the expected result Documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality […]
Interview questions mostly asked during technical round in Production : 01. Q. Which type of tablets are exempted from Disintegration testing? A. Chewable Tablets 02. Q.What are the common variables in the manufacturing of tablets?A.· Particle size of the drug substance· Bulk density of drug substance/excipients· Powder load in granulator· Amount & concentration of binder· […]
Pharmaceutical manufacturers must validate their cleaning process to ensure compliance with cGMP regulations. Minimizing equipment downtime has the potential to impact the efficiency and economics of pharmaceutical production. The main purpose of cleaning validation is to prove the effectiveness and consistency of cleaning in a given pharmaceutical production equipment to prevent cross contamination and adulteration […]
Steam Dryness: The measure of the water content of steam deliverd to the sterilizer chamber.Acceptable values are 0.9 or greater (<10% water) for non-metallic loads and 0.95 or greater (<5% water) for metallic loads. Wet steam can cause an unsterile load in two ways: Insufficient energy delivered to the load to sterilize. “wet packs”, making […]
