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 Errors Regulatory expectations {(as per…
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 rotary travel system and Control…
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 the required efficiency. The various…
Quality management Review
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, processing, packing, or holding do…
Sterilization and depyrogenation tunnel [toggle title=”What is Endotoxin?” state=”close”]Endotoxin, toxic substance bound to the bacterial cell wall and released when the bacterium ruptures or disintegrates. Endotoxins consist of lipopolysaccharide and lipoprotein complexes. The endotoxin complex contains many cell wall components including, but not limited to, phospholipids, lipoproteins, and lipopolysaccharides. Lipopolysaccharide is the biologically active portion…
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 aseptic procedures are adequate to…
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 to demonstrate that your cleaning…
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 to PIC/S Document PI 006….
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, whether or not the batch…
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. The company manufactured an OTC…
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 and can be used as…
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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 into concrete action plans … Because…
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 Procedure for Temperature, Relative Humidity,…
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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 materials Packing materials Identification of…
Tablet Defects and Remedial action in Pharma In the routine manufacture of tablets, various defects are observed. The source of the problem or the defect is the formulation, the compression or coating equipment, or a combination of these. Tablet defects are deficiencies that are usually encountered in tablet formulation. Depending on experience, machinery, and excipient…
USFDA 483 Observations – Top 5 Common Observations Quality control procedures not in writing fully followed Scientifically sound laboratory controls not established Investigations of discrepancies, failures to adequately review Absence of Written Procedures for production and process controls Written procedures not established/followed for cleaning and maintenance equipment Lack of or inadequate procedures (CAPAs) Lack of…
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