Tag Archives: Reggio Calabria

New EU Requirements for Qualification & Validation Updated version of Annex 15 ◦ Qualification and Validation Draft released in February 2014 Final version released on the 30th of March , 2015 Will be effective on 01 October 2015 4/3/2015 3 Improved Annex 15 May be used as supplementary optional guidance …

Concept of URS,DQ,IQ,OQ,PQ in Pharma Introduction  Validation User Requirement Specification.(URS) Phase of validation Design qualification (DQ) Installation Qualification (IQ) Operation Qualification (OQ) Performance Qualification (PQ) Maintenance Qualification (MQ) Component Qualification (CQ) Instrument Re-Qualification According to the Food and Drug Administration (FDA), the goal of validation is to: “Establish documented evidence …

Good storage practices for pharmaceuticals as per regulatory Guideline 1. Introduction 2. Glossary 3. Personnel 4. Premises and facilities 5. Storage requirements 6. Returned goods 7. Dispatch and transport 8. Product recall 1. Introduction The storage, transportation and distribution of pharmaceuticals. The stability testing of pharmaceutical products containing well-established drug …

The role of dissolution in drug development Oral dosage forms remain one of the most flexible and effective treatments available to patients. Dissolution testing is a requirement for all solid oral dosage forms and is used throughout the development life-cycle for product release and stability testing. It is a pivotal …

  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 …

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 …

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 …

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 …

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 …

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 …

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 – …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …