Stability Definition These studies provide information about the packaging in that it is not reactive, additive, or absorptive so that the identity, strength, quality and purity of the drug product is not affected, also to provide clearance on stability process flow. To assessment of the stability characteristics of all drug products manufactured / packaged…
CLEANING VALIDATION IN PHARMACEUTICAL INDUSTRY – AN OVERVIEW Manufacturing of Pharmaceutical products shall demonstrate a control to reproduce consistently the desired quality of product, wherein the control of cross-contamination plays an important role. An effective cleaning shall be in place to provide documented evidence that the cleaning methods employed within a facility consistently controls potential…
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An Introduction to Clinical Trials What is Clinical Trials? A properly planned and executed clinical trial is a powerful experimental technique for assessing the effectiveness of an intervention What is an investigational product? ‘a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products…
Phases of clinical trials Contents • Introduction:Clinical research • Drug development phases • Pre-Phase 1 activities • Phases of Clinical trial • Regulatory approvals: IND & NDA • Summary of Clinical trial phases INTRODUCTION • Clinical trial is a systematic investigation in human subjects for evaluating the safety & efficacy of any new drug. •…
Determining Whether to Submit an ANDA or a 505(b)(2) Application in USFDA Part II SUBMISSION THROUGH THE APPROPRIATE ABBREVIATED APPROVAL PATHWAY A. Regulatory Considerations for ANDAs and 505(b)(2) Applications 1. Duplicates FDA generally will refuse to file a 505(b)(2) application for a drug that is a duplicate of a listed drug and eligible for approval…
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Determining Whether to Submit an ANDA or a 505(b)(2) Application in USFDA This guidance is intended to serve as a foundational guidance to assist applicants in determining which one of the abbreviated approval pathways under the Federal Food, Drug, and Cosmetic Act (FD&C Act) is appropriate for the submission of a marketing application to FDA…
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Current Trends in Cleaning Validation Rings on Buffer and Media Tanks Health based limits FDA Trends Process Understanding Trend 1: Rings in Buffer tanks Initial Incident Discovery Background • Cleaning processes are designed based on – nature of the soil – condition of the soil – surface material – cleaning factors • ALI rings…
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…
