MOST FREQUENTLY ASKED QUESTIONS What parameters are considered during the performance qualification of HVAC? The following parameters are to be considered during the performance qualification of HVAC: 1. Calibration test certificates of instruments 2. Training records of the validation team 3. Pressure drop across the HEPA & fine filters 4. …

Microbiological Efficacy of the Cycle Validation studies that demonstrate the efficacy (lethality) of the production cycle need to estabilished. A sterility assurance of 10 or -6 better should be demonstrated for any terminal sterilization process. The level of sterility assurance should be demonstrated for all parts of the drug product …

Microbiological Monitoring of the Environment The microbiological monitoring program shall be performed during routine production and media fills and procedure for microbiological monitoring program are clearly defined in SOP. Microbiological monitoring – frequency of monitoring, type of monitoring, sites monitored, alert and action level specifications, and clearly defined procedure for …

TOOLS FOR QUALITY IMPROVEMENT PART – I teams of people working together on projects in order to achieve pre-defined quality objectives or Eliminate the root cause(s) of a specific problem is an integral part of ST culture. To ensure that all these team members are sufficiently equipped to undertake their …

Human Errors Understanding Human Errors Regulatory expectations The current way of handling human errors Types of human errors Investigation of human errors CAPAs Case study Human Error Is The Leading Cause Of GMP Deviations – 25-60% of the deviations / Incidents in the companies are caused by human errors Human …

VIAL WASHING MACHINE An automatic rotary vial washing machine with an integral washing tank for recycled water, with multiple washing stations, is designed to clean the glass vials internally and externally with different washing media in six stages at the rated output of 120 vials per minute. Operation by the …

Sterile Pharmaceutical Products The production of sterile preparations should be carried out in clean areas, entry to which should be through airlocks for personnel and for equipment and materials. Clean areas should be maintained to an appropriate standard of cleanliness and supplied with air that has passed through filters of …

CHANGE MANAGEMENT PROTOCOL (PACMP) A Change Management protocol (PACMP) is a regulatory tool that provides predictability and transparency in terms of the requirements and studies needed to implement a change that Provides an opportunity for lower reporting category when implementing changes. PACMP tools that allow continued opportunities for streamlined change …

FDA 483 Warning Letter Dated MAY 23, 2022 This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211). Because your methods, facilities, or controls for manufacturing, …

Sterilization and depyrogenation tunnel        

Question and Answer Part -1 Question  – 1: What is Media fill f Aseptic Process Simulation (APS)? Answer: A media fill or Aseptic Process Simulation (APS) is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium, in place of the drug solution, to test whether the …

FDA 483 Warning Letter Dated JUNE 14, 2022 1. Failure to perform repackaging of API under appropriate CGMP to avoid potential cross-contamination. During your API repackaging and relabeling operations, including highly potent drugs such as testosterone, estradiol, betamethasone, tamoxifen, and opioids, your firm failed to conduct adequate cleaning validation studies …

ASEPTIC PROCESSES VALIDATION AS PER PIC/S Validation of aseptic processes relies upon prospective, concurrent, and retrospective validation as well as re-validation. Prospective studies include installation and operational qualification for a new or renovated facility as well as product simulation studies and a prospective process validation with the original product according …

FDA – Warning Letter – 10 JUNE 2022 This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals 1. The company failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, …

FDA 483 Warning Letter Dated JUNE 22, 2022 1. Each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)) and the company failed to prove this procedure. …

Unlocking Success with User Requirement Specification: Coating Machine URS In any project or system development, understanding and capturing user requirements accurately is crucial for success. User Requirement Specification (URS) is a structured document that serves as a foundation for defining and documenting user needs, expectations, and functional requirements. It forms …

What are the different types of Quality Management systems (QMS)? Quality management is an essential system that every company should have in place. It is a set of practices that help companies identify, measure, and control the quality of their products. They help identify potential hazards before they become problems …

What is future mapping? “Future Mapping” is a remarkable new technology for problem-solving, creativity, and innovation. It involves a map with six areas to create an action scenario to achieve your goal … far more advanced than current methods … … reverses existing ideas on goal achievement … … turns thoughts …

 sop-of-Revalidation/Requalification of HVAC system objective Scope Responsibility Qualification team Abbreviation and definition Pre-requisites Precautions and instruction (Health, Safety, and Environment) Air velocity, the Air volume, and air Change Per hour measurement Procedure for HEPA Filter integrity Procedure for non-viable particle count Procedure for viable particle count Recovery Study Airflow Visualization …

OUT OF SPECIFICATIONS (OOS) Out of Specification (OOS) means the test result that falls outside the specifications or acceptance criteria which has been specified in the official compendia monographs or the finished product specification in registration dossiers. OOS IS OBSERVED IN THE ANALYSIS OF: Stability study Finished product In-process Raw …