Establishment of Limits in Cleaning Validation

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 … Read more

Sampling, Rinsing, Rinse Samples and Detergents in cleaning Validation

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 … Read more

Documentation in cleaning validation

Documentation in cleaning validation 1.0 Detailed cleaning procedure(s) are to be documented in SOPs 2.0 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 … Read more

Validation of Cleaning Processes

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 which has been exposed to a product and the cost of permanently dedicating the … Read more

Computerised systems – EU GMP Annex 11

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). … Read more

Sampling of starting and packaging materials: Glycerol as per EU GMP

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 … Read more

Question and Answers on WHO GMP

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 … Read more

Hygiene and cleanliness programs as per USFDA GMP in pharmaceuticals

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 … Read more

Risk-based approach as per EU Good Manufacturing Practice specific to Advanced Therapy Medicinal Products

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 … Read more

Premises and Equipment as per EU GMP EudraLex

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 … Read more

Pharmacovigilance

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 … Read more

Levels of Cleaning in cleaning Validation

Levels of Cleaning in cleaning Validation Introduction The manufacturing process of an Active Pharmaceutical Ingredient (API) typically consists of various chemical reaction and purification steps followed by physical changes. In general, early steps undergo further processing and purification and so potential carryover of the previous product would be removed. The level of cleaning required in order to ensure … Read more

EU and US GMP/GDP: Similarities and Differences

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

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 ‘ … Read more

USFDA Generic Drugs: Questions & Answers

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 … Read more

PROCEDURE FOR OPERATION OF HUMIDITY CONTROL OVEN (NEWTRONIC)

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 … Read more

USFDA – INTRODUCTION TO DRUG REGULATION

USFDA – INTRODUCTION TO DRUG REGULATION Basic Mission Safety Efficacy Drugs Medical Devices Truthful Labeling Adulteration Misbranding FDA’s Structure and Organization The Commissioner President Appoints,  Senate Confirms 4th Tier in HHS Not an Independent Agency Insulation From Politics (Old Days) Few Political Appointees Scientific Basis of Its Decisions Visibility Protects It From Presidential Pressure Does … Read more

USFDA Foreign Priorities, Inspections and Compliance

USFDA Foreign Priorities, Inspections and Compliance Priorities Challenges of globalization cGMP deficiencies Comparison Post inspection regulatory actionsAdvance Regulatory Science:  the science of developing new tools, standards and approaches to assess the safety and effectiveness, quality and performance of FDA-regulated productsStrengthen the safety and integrity of the global supply chain A paradigm shift is required to … Read more

USFDA Regulatory Inspection Do’s and Dont’s

USFDA Regulatory Inspection Do’s and Dont’s FDA Audit – The Do and Don’t List Pre-inspection Do’s: • Have a Company Inspection Manual • Have a trained Company Inspection Team • Identify what FDA (or the state) may inspect • Be familiar with relevant sections of FDA’s Investigations Operations Manual. Company Inspection Manual should include policies … Read more

DATA INTEGRITY: ALCOA AND ALCOA PLUS

DATA INTEGRITY: ALCOA AND ALCOA PLUS The guidance has been written to apply to on-site inspections of those sites  performing manufacturing (GMP) and distribution (GDP) activities. The principles  within this guide are applicable for all stages throughout the product lifecycle. The  guide should be considered as a non-exhaustive list of areas to be considered during  inspection. ALCOA TERM – … Read more