Steps in Managing the Pharma Audit Introduction To achieve its’ objective efficiently and cost-effectively an audit should be thoroughly planned, carefully structured, systematically performed, faithfully reported, and remedial actions progressed to a timely and satisfactory conclusion. As with most issues involving people, clear and effective communication with the relevant stakeholders is essential if business benefits are to be maximised…
Types of Audit in Pharma company Auditing Audit types General Considerations The quality audit has been defined in a number of ways e.g. “An independent and formal review to determine the degree to which processes/products conform to standards set forth for them”, or “A systematic and independent examination to determine whether activities and related results comply with planned…
Technical Report Series (TRS) Biologicals Chronological listing 68th report: TRS 1011: 2017 67th report: TRS 1004: 2016 66th report: TRS 999: 2015 pdf, 1.31Mb 65th report: TRS 993: 2014 64th report: TRS 987: 2013 63rd report: TRS 980: 2012 pdf, 2.22Mb 62nd report: TRS 979: 2011 pdf, 3.23Mb 61st report: TRS 978: 2010 pdf, 3.70Mb 60th…
ANALYTICAL METHOD VALIDATION Principle General Pharmacopoeial methods Non-pharmacopoeial methods Method validation Method verification Method transfer Revalidation Characteristics of analytical procedures PRINCIPLE 1.1 This appendix presents some information on the characteristics that should be considered during validation of analytical methods. Approaches other than those specified in this appendix may be followed and may be acceptable. Manufacturers should choose…
Establishment of Limits in Cleaning Validation The rationale for selecting limits for product residues should be logical and based on the materials involved and their therapeutic dose. The limits should be practical, achievable, and verifiable. In establishing product residual limits, it may not be adequate to focus only on the main reactant since by products/chemical…
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Sampling, Rinsing, Rinse Samples and Detergents in cleaning Validation Sampling: There are two general types of sampling that are considered to be acceptable, direct surface sampling (swab method) and indirect sampling (use of rinse solutions). A combination of the two methods is generally the most desirable, particularly in circumstances where accessibility of equipment parts can…
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Documentation in cleaning validation Detailed cleaning procedure(s) are to be documented in SOPs A Cleaning Validation Protocol is required to define how the cleaning process will be validated. It should include the following: The objective of the validation process; Responsibilities for performing and approving the validation study; Description of the equipment to be used; The…
Validation of Cleaning Processes As a general concept, until the validation of the cleaning procedure has been completed, the product contact equipment should be dedicated. In a multi-product facility, the effort of validating the cleaning of a specific piece of equipment that has been exposed to a product and the cost of permanently dedicating the…
Computerised systems – EU GMP Annex 11 1. Appropriate controls for electronic documents such as templates should be implemented. Are there any specific requirements for templates of spreadsheets? H+V February 2011 Templates of spreadsheets help to avoid erroneous calculations from data remaining from previous calculations. They should be suitably checked for accuracy and reliability (annex 11 p7.1)….
Sampling of starting and packaging materials: Glycerol as per EU GMP EU GMP guide annexes: Supplementary requirements: Annex 8: Sampling of starting and packaging materials: Glycerol 1. What is the background regarding international incidents of glycerol contamination? H+V December 2007 There is a history of sporadic reports from around the world of supplies of glycerol contaminated with diethylene glycol…
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Question and Answers on WHO GMP Why is GMP important? Poor quality medicines are not only a health hazard, but a waste of money for both governments and individual consumers. Poor quality medicines can damage health A poor quality medicine may contain toxic substances that have been unintentionally added. A medicine that contains little or…
Hygiene and cleanliness programs as per USFDA GMP in pharmaceuticals High standards of personal hygiene and cleanliness are essential. Hygiene programs should be established Eating, drinking, chewing or smoking, as well as the storage of food or personal medication should be prohibited in the production and storage area. Direct contact should be avoided between the operator’s hands…
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Risk-based approach as per EU Good Manufacturing Practice specific to Advanced Therapy Medicinal Products Introduction ATMPs are complex products and risks may differ according to the type of product,nature/characteristics of the starting materials and level of complexity of the manufacturing process. It is also acknowledged that the finished product may entail some degree of variability due to…
Premises and Equipment as per EU GMP EudraLex PRINCIPLE Premises and equipment must be located, designed, constructed, adapted and maintained to suit the operations to be carried out. Their layout and design must aim to minimise the risk of errors and permit effective cleaning and maintenance in order to avoid cross-contamination, build-up of dust or…
Pharmacovigilance Pharmacovigilance: Pharmacovigilance WHO defines pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects of marketed medicines or those under trial. The drug regulatory agencies have the responsibility of having a well-established pharmacovigilance system to monitor adverse reactions of drugs, during the drug development phase and later…
Levels of Cleaning in Cleaning Validation The manufacturing process of an Active Pharmaceutical Ingredient (API) typically consists of various chemical reactions and purification steps followed by physical changes. In general, early steps undergo further processing and purification so potential carryover of the previous product would be removed. The level of cleaning required to ensure that…
EU and US GMP/GDP: Similarities and Differences Reference: McGee Pharma International-Nov. 2016 Thank you for visit and for more pharma updates click here – https://pharmaguidances.com
Procedure for operation of Autotitrator (METTLER TOLEDO). Quality assurance OBJECTIVE To lay down the procedure for operation of AUTO TITRATOR (METTLER TOLEDO DL50) SCOPE This procedure is applicable to Autotitrator (METTLER TOLEDO DL50). RESPONSIBILITY Quality Control Executive/Officer. ACCOUNTABILITY Head Quality Control. PROCEDURE FOR CLEANING Check that the power supply to the instrument is switched ‘…
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USFDA Generic Drugs: Questions & Answers What are generic drugs? A generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. These similarities help to demonstrate bioequivalence, which means that a generic medicine works in the…
PROCEDURE FOR OPERATION OF HUMIDITY CONTROL OVEN (NEWTRONIC). Quality assurance OBJECTIVE To lay down the procedure for operation of Humidity control oven. Model : NEC 228R 10S SCOPE This SOP shall be applicable for the operation of Newtronic make Humidity control oven (30°C/65%RH) &. (40°C/75%RH) RESPONSIBILITY QA Officer / Executive ACCOUNTABILITY Assistant Manager Quality Assurance…
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