Wednesday, October 31, 2012

Component Of Master Validation Plan

Content may include the following descriptions (but not be limited to):

1. Introduction
1.1 Project Description
1.2 What a Validation Master Plan Is
1.3 Scope of Validation Master Plan
1.4 Definition for the Term Validation
1.5 Validation Team Member
1.6 Validation Team Responsibility

2. Concept of Qualification or Validation
2.1 Fundamentals
2.2 Concept of a Validation Life Cycle
2.3 Elements of Validation
2.4 Documentation Format of Qualification Programs
2.5 Numbering System

Basic Concept Of Validation

1. Definition of Validation
  •   Action of proving, in accordance with the principles of good manufacturing practice, that any procedure, process, equipment, material, activity, or system actually leads to the expected result
  • Documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes and characteristics
  • Obtaining and documenting evidence to demonstrate that a method can be relied upon to produce the intended result within defined limits
  • Action to verify that any process, procedure, activity, material, system, or equipment used in manufacture or control can, will, and does achieve the desired and intended results.

Interview Questions for Pharmaceutical industry related jobs (QA,QC,Production,RA,f&d) for B.pharma /M.pharma (Part 1)

  • Interview questions mostly asked during technical round in Production :

01. Q. Which type of tablets are exempted from Disintegration testing?
A. Chewable Tablets

Cleaning Validation And Its Importance In Pharmaceutical Industry

Pharmaceutical manufacturers must validate their cleaning process to ensure compliance with cGMP regulations. Minimizing equipment downtime has the potential to impact the efficiency and economics of pharmaceutical production. The main purpose of cleaning validation is to prove the effectiveness and consistency of cleaning in a given pharmaceutical production equipment to prevent cross contamination and adulteration of drug products with other active ingredients like unintended compounds or microbiological contamination, leads to prevent several serious problems and also useful in related studies like packaging component cleaning validation. So it is necessary to validate the cleaning procedures to ensure safety, efficacy, quality of the subsequent batches of drug product and regulatory requirements in Active Pharmaceutical Ingredients (API) product manufacture. The benefits due to cleaning validation are compliance with federal regulations, identification and correction of potential problems, previously unsuspected which could compromise the safety and efficacy of drug products. In this article cleaning, validation and importance are discussed in brief

Steam Quality Parameters And Effects Of Their Deviations From Accepted Values

Steam Dryness:

The measure of the water content of steam deliverd to the sterilizer chamber.
Acceptable values are 0.9 or greater (<10% water) for non-metallic loads and 0.95 or greater (<5% water) for metallic loads.
Wet steam can cause an unsterile load in two ways:
  • Insufficient energy delivered to the load to sterilize.
  • “wet packs”, making the sterile barrier material surrounding the load less of a barrier and compromising sterility assurance.

Steam Purity Checks Before Start Sterile Operation In Biopharmaceutical Industries

Steam Quality Checks
In the pharmaceutical manufacturing and health-care industries, there are basically two types of steam–process steam and pure steam. Process steam is also known as plant steam, black steam, utility steam, boiler steam etc. Pure steam is sometimes known as clean steam.

Process steam is defined as a general purpose steam whose quality is not been optimised for sterilisation. Where it is not intended to be in direct contact with medical devices, medicinal or culinary products, no specific physical, chemical or biological contamination limits are set. The steam may contain various volatile additives (such as those intended to inhibit corrosion in condensate return pipes) which are unacceptable for topical or parenteral administration to human beings.

7 steps of Corrective Action Preventive Action (CA-PA)

CAPA (Corrective Action Preventive Action) and failure investigation become more and more important for the pharmaceutical industry. This becomes clear in a series of guidance documents. Above all with the ICH Q10 document, CAPA was introduced as a new quality-assuring tool. This document states e. g. that a pharmaceutical company should have a system in place for taking corrective and preventive measures (CAPA). These can, among other things, result from complaints, deviations, recalls, observations in audits and inspections or monitoring results. The investigations within the system should aim at finding the actual cause. The outcome should be that process and product are better understood and improvements are derived.

Quality Assurance(QA) role In Pharma Industry

Technology Transfer :
  • Receipt of product design documents from Research Center.
  • Distribution of documents received from Research Center (RC).
  • Checking & approval of documents generated based on RC documents i.e. Batch Manufacturing Record.
  • Scale-up and validation of product

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