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Audit and compliance

Audit readiness Reference https://www.fdanews.com/ext/resources/files/The_Food_And_Drug_Letter/2013/Inspection-Readiness-ExecSeries.pdf https://ispe.org/initiatives/regulatory-resources/gmp/audit-checklist# Before start of audit we need to review past audits and note indication of possible problem areas and items, if any ensure that were identified for corrective actions in a previous audit. If not aware about facility learn what products being produced and how it is organised with personal and function. To have systematic audit checklist to be prepared and alongwith notebook it needs to be utilised (notebook required to make detailed entries while audit and checklist is to guide auditor). Atleast three production batches to be selected For thorough analysis to include- a) Traceability of all components or materials used in that batch. b) Documentations of raw materials or components, inprocess and finished goods testing for subject product batches. c) Warehousing and distribution reco...
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Change Management System

US Market (Supplement): Post approval drug manufacturing supplement for NDAs/ ANDA submitted to FDA for Major or Moderate manufacturing change. Major change - If a manufacturing change is considered to be major, an applicant must submit and receive FDA approval of a prior-approval supplement (PAS) before the drug product made with the change is distributed. Moderate change- If a manufacturing change is considered to be moderate, an applicant must submit a supplement at least 30 days before the drug product is distributed (a CBE-30 supplement) or, in some cases, submit a supplement at the time of distribution (a CBE-0 supplement).  “CBE” means “changes-being-effected”. Post manufacturing supplement - 1. CBE 0 (Change being effected before 00 days): 2. CBE 30 (Change being effected before 30 days): 3. PAS (Prior approval supplement): EUROPE Market (Variation): A variation to the terms of a marketing authorization is an amendment to the contents of the docume...
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Critical quality events-QP

Critical quality events-QP EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use - Annex 16: Certification by a Qualified Person and Batch Release Quality Event: The event occurred during manufacturing / analysis of batch / lot or event occurred during the batch / lot is in the distribution system or as a market feedback which is likely to have potential impact on finished product Qualified Person (QP): QP is the person responsible for ensuring that each individual batch has been manufactured and checked in compliance with laws in force in the Member State where certification takes place, in accordance with the requirements of the marketing authorization (MA) and with Good Manufacturing Practice (GMP) Periodic Events Notification- Quality events summary report shall be prepared on quarterly basis 1.     Incidents- Incidents which have a systemic effect: · Any validation / qualificat...
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Steam sterilization

Steam In Place - Steam In Place vs Sterilize In Place- Steam in place term used to describe in situ sterilization using steam. Sterilize in place term used to describe in situ sterilization using various types of gaseous or liquid sterilizing agents including steam. Terminal sterilization = Steam under pressure - A probability of no more than one no-Sterile unit in a million (10-6) is readily achievable. Aseptic - A controlled process or condition in which the level of microbial contamination is reduced to the degree that microorganisms can be excluded from a product during processing.
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Air velocity measurement and correlation to smoke study

Air velocity measurement As part of risk assessment this evaluation should also consider the selection of locations for the critical control points for monitoring air velocity as well as viable and non-viable particles. 1. Problem Statement- Where should airflow velocity measurements be taken with respect to a filling line or other aseptic processing areas? Recommendation Airflow velocity measurements should be taken at locations where meaningful and reproducible results can be obtained. This is typically at a distance of 6 inches from the filter face . Rationale for Recommendation The primary reason for airflow velocity measurements in unidirectional airflow areas (e.g., areas where product, product contact packaging components, and product contact surfaces are exposed) is to assure there is adequate airflow to protect the materials from external airborne contamination . Accurate measurements can be taken and changes over time detected when airflow velocities are e...
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Smoke Study

USP general chapter - 797 1. Unidirectional airflow 2. Sweeping action over and away from the product under dynamic conditions. 3. It is useful in identifying eddy currents and recirculation of air flow as a means of assessing risk of contamination in critical areas within a clean room. First air should contact critical components or products before contacting anything else. It should be free of eddy currents or deviant air that can act as a channel or reservoir for contaminants. It is important to evaluate air flow patterns to assure that these patterns do not pose a risk of distributing particles from sources such as surrounding environment, personal, operations, materials or equipment. These tests are used to demonstrate that airflow under operational conditions doesn't contribute to contamination risk. Regulatory bodies requires documented air pattern analysis with written conclusions including the effects of the aseptic interventions in critical areas. Smoke s...
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Filter Integrity

Bubble point: The measured differential gas pressure which a wetting liquid (e.g., water, alcohol, product) is pushed out of the largest pores of a wetted porous membrane and a steady stream of gas bubbles or bulk gas flow is detected. Bubble point test: A test to indicate the maximum pore size of a filter. The differential gas pressure at which a liquid (usually water) is pushed out of the largest pores and a steady stream of gas bubbles is detected from a previously wetted filter under specific test conditions. Used to test filter integrity with specific, validated, pressure values, wetting liquids and temperatures for specific pore-size (and type of) filters. Water intrusion test/ HydroCorr test : The HydroCorr test is based on the fact that water is repelled by the pores Hydrophobic filters by surface tension and capillary forces. The HydroCorr test is a highly sensitive, non-alcohol, water flow integrity test for hydrophobic membrane filters. The minimum pressure require...
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