QA & QC

Quality Excellence & Quality Culture Check Addressing the sources of variability and defects is critically important when the failure rate is excessive or warranty obligations hurt profitability. The Quality Excellence Program helps business leaders, quality managers, and functional specialists to systematically improve process capability and consistently meet customer requirements at the lowest non-performance …

ANNUAL PRODUCT QUALITY REVIEW (APQR)/ PRODUCT QUALITY REVIEW (PQR) This Annual product Quality review should be conducted with the objective of verifying the repeatability of existing processes, the appropriateness of current specifications for raw materials and finished products, identifying any trends and identifying any improvements to products and processes. It …

Quality inspection (Self-inspections & Benefits of Self Inspection) Principle Importance and Benefits of Self Inspection What is needed Scope How can self-inspection be conducted Inspection Techniques Example of Self-Inspection Plan Who should be involved Self-inspection report Points to consider when performing self-inspection Stages of Self-Inspection Advantages & Disadvantages of Checklist …

Checklist for Do’s and Don’ts for Dissolution Analysis Checklist for Do’s Always check the availability of chemicals and required glassware for the analysis. Before loading dissolution check the Calibration status of the instrument. Always check the water level of the dissolution bath (without a bowl). Check the clarity of the water …

Checklist for Do’s and Don’ts for Using Glassware for Analysis Checklist for Do’s Use Class A Glassware for analysis Use  transparent glassware for analysis Before using glassware for analysis check for cracks or breakage. Use exact capacity glassware by checking the marking of capacity e.g. ‘20’ flask not to be used …

Checklist for Do’s and Don’ts for Sample preparation of temperature / light-sensitive material and product Checklist for Do’s In the case of temperature-sensitive / light-sensitive material collect samples from the respective storage area & allowed them to attain room temperature before using i.e weighing, pipetting, etc. During analysis close the sample …

DO’s & DON’Ts For Column care to avoid/Minimize incidences 1.0 New HPLC Columns(Except Silica Columns for Normal Phase) DO’s Before using the new column wash the column with water followed by an appropriate solvent mixture. For Silica Column for washing use solvent as Given in the Column Certificate. DON’Ts Don’t …

Checklist for Precautions during Sample Dilution /preparations in Wet Labs Checklist for Do’s Use a bulb pipette for further dilution. During pipetting Wipe off the tip with clean tissue paper. Adjust the meniscus to eye level by discarding the solution to waste. Transfer the amount to the volumetric flask. Touch the …

SOP On SOP – Initiation of new SOP In Pharma Industry The fundamental purpose of an SOP in pharma is to provide clear and concise instructions for the consistent execution of routine operations within an organization. By offering a step-by-step guide on how tasks should be carried out, SOPs aim …

REGULATORY IMPACT ON OOS Stability study required OOS should be reported to RA OOS batch should not be sold to the Regulatory market OOS batch can not be blended with a fresh approved batch OOS batch can not be directly sold to the market Reporting Test Result Result: Averaging Appropriate …

OOS RECORDING PROCEDURE REPORTING TO THE LABORATORY SUPERVISOR RECORDING AND NUMBERING OF OOS INVESTIGATION BY ANALYST LABORATORY TESTING APPROVAL BY LAB. SUPERVISOR TESTING BY ANALYST PROCEDURE OF OOS INVESTIGATION: A written record of the review should include the following information A clear statement of the reason for the investigation. A …

REGULATORY RECOGNITION OF SECONDARY WORKING STANDARDS (1) Human Drug CGMP Notes, Vol 9, Number 3, 2001 (Internal FDA Publication): Q: Can a company use reference standards from sources other than the USP? A: Yes. Using a source other than USP can be acceptable provided the reference standard incorporates the critical …

BET and sterility validation of microbiology  BET and sterility validation of microbiology consists of the following:- Protocol No. for BET and sterility validation should be written in format PR/MV/AA/ BB/CC/DD and report No. should be written in format RP/MV/AA/ CC/DD . PR refers to protocol, RP refers to Report, MV …

Process validation protocol A written plan stating how validation will be conducted, including test parameters, product characteristics, production and packaging equipment, and decision points on what constitutes acceptable test results. The process validation protocol is defined as the experimental plan that design thoroughly the validation programmed. Protocol of the Process …

GMP Inspection HPLC Checklist HPLC is an abbreviation for High-Performance Liquid Chromatography. “Chromatography” is a technique for separation, “chromatogram” is the result of chromatography, and “chromatograph” is the instrument used to conduct chromatography. HPLC dedicated to molecular separation called columns and high-performance pumps for delivering solvent at a stable flow rate …

Change Management In Pharma Change Management in Pharma is a formal process for making planned and unplanned changes to the existing approved procedure and policy. The primary objective of Change Management in Pharma is to provide standardized methods and procedures to meet the change management requirements supporting operations. Change control …

Hold Time Study Protocol 1. Objective \ Scope 1.1. Hold time study data shall give the assurance of the maximum allowable hold times for bulk and in-process drug products. Generally, one lot can be used for validating hold times if any inconsistency results were observed then another two lots can …

CRITICAL AND MAJOR DEFICIENCIES Compliance and enforcement measures are dependent upon a number of factors, including the significance of violations such as a “Critical” deficiency and a large number of “Major” deficiencies, the history of the site, potential risks to products, and assessment of the manufacturer’s proposed corrective actions. Where …

GMP Deficiencies in Pharmaceutical Industry “Critical and Major deficiencies” The GMP Deficiencies findings of a Good Manufacturing Practice (GMP) inspection can have a substantial impact on both your organization and, subsequently, public health. If the GMP Deficiencies found are classified as significant, they may necessitate cessation of manufacturing activities and/or product withdrawal from the …

Isolators In Pharma Industry Isolators are clean air devices providing complete separation between an aseptic process (hazardous/non-hazardous), the technical personnel, and the surrounding work environment. Isolators are generally used in applications requiring a high degree of protection from external elements or contaminants, and they can serve as alternatives to sophisticated …