Part III: Qualification of Water and Air Handling Systems

B. Validation life cycle

1. Determination of Quality Attributes

In performing the validation, defining the quality attributes—that is, gaining a clear understanding of the required quality and intended use—is the most important issue, and should be determined before starting the validation. Without defining required quality attributes we cannot establish validation protocols, which are the basis of all validation studies.

2. The Validation Protocol

A validation protocol is defined as 

"A written plan stating how validation will be conducted and defining acceptance criteria. For example, the protocol for a manufacturing process identifies process equipment, critical process parameters/operation ranges, product characteristics, sampling, and test data to be collected, number of validation runs, and acceptable test results."

Part II: Qualification of Water and Air Handling Systems

II. VALIDATION STRATEGY

A. Validation Concept

To prove the performance, one must demonstrate (document) that the processes or systems consistently produce the specified quantity and quality of water and/or air when operated and maintained according to specific written operating and maintenance procedures. In other words, validation involves proving

1. Engineering design

2. Operating procedures and acceptable ranges for control parameters

3. Maintenance procedures

To accomplish this, the system must be carefully designed, installed, and tested during and after construction, and therefore for a prolonged period of time under all operating conditions.

Recent Facts of Indian Pharma Industry

SMS service for awareness on cheaper drugs:

Sep 1, 2012, 12.59PM IST, The writer has posted comments on this article PTI

NEW DELHI: The Department of Pharmaceuticals in the Ministry of Chemicals and Fertilisers is planning to launch a SMS service providing information about affordable alternatives to medicines prescribed by doctors.The Short Message Service (SMS) facility could help poor patients find cheaper alternatives to medicines prescribed by doctors.

The Ministry of Health and Family Welfare has sought that all 348 drugs listed in the National List of Essential Medicines, 2011 should be brought within the purview of the Drug Price Control Order (DPCO) so that there should be minimum impact on the expenses of consumer.

Part I: Qualification of Water and Air Handling Systems

 I. PURPOSE OF VALIDATION

High-quality water and air are essential for the manufacture of pharmaceuticals. Water is the most commonly used raw material in pharmaceutical manufacturing; it is indirectly used in the manufacture of all dosage forms for cleaning manufacturing equipment, and is also used as a major component which constitutes injectable products. It is the one raw material that is usually processed by the pharmaceutical manufacturer prior to use because it cannot be used as supplied by the vendor. Water should be regarded as one of major raw materials for the manufacture of pharmaceuticals whether or not it remains as a component of the finished dosage form or is eliminated during the manufacturing process. Water is thus an important raw material in GMP and in validating the manufacturing process.

Brief Idea On HVAC System

Introduction:

 Heating, ventilation and air-conditioning (HVAC) play an important role the manufacture of quality pharmaceutical products. A well designed HVAC system will also provide comfortable conditions for operators. HVAC system design influences architectural layouts with regard to items such as airlock positions, doorways and lobbies. The architectural components have an effect on room pressure differential cascades and cross-contamination control. The prevention of contamination and cross-contamination is an essential design consideration of the HVAC system.

About HEPA filters used in HVAC system

About HEPA (High efficiency particulate air)

 

High-Efficiency Particulate Air or HEPA  is a type of air filter. It is a type of filter which has high efficiency to filter out about 99.997% that is why they are termed as High efficiency particulate air filter,HEPA filters are made up of a mesh of fiber glass fibers of thickness ranging from 0.5 to 2 micrometer and are closely packed with each other with as low clearance as 0.3μm which may be bit greater.

Particles in air are trapped in to HEPA filter fibers when air caring these particles is blown or passed through these fibers, by mechanism of interception (particles adhere to fibers), impaction (particles embed in to the gap) and diffusion and then blocking, particles with lower particle size than the gap between these fibers are also trapped as the result above mechanisms fiber diameter, filter thickness, and face velocity are the factors which affect the efficacy of the HEPA filter.

Guide To Inspections Validation Of Cleaning Processes

I. INTRODUCTION

This article is written to guide and design how to set up validation procedure, one must recognize that for cleaning validation, as with validation of other processes, there may be more than one way to validate a process. In the end, the test of any validation process is whether scientific data shows that the system consistently does as expected and produces a result that consistently meets predetermined specifications.This guide is intended to cover equipment cleaning for chemical residues only.

Brief Introduction Of ICH Guidelines

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration. The purpose of ICH is to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines by recommending ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration. Harmonisation would lead to a more economical use of human, animal and material resources, and the elimination of unnecessary delay in the global development and availability of new medicines while maintaining safeguards on quality, safety, and efficacy, and regulatory obligations to protect public health.

Cleanroom Classification and Examples for Working Steps According to EU GMP Guide

Cleanroom Classification

The current demands in today’s pharmaceutical industry for quality control and quality assurance have been driven by the aspiration to deliver consistently high quality and safe products to the consumer. The standards that are set to meet this goal are exorbitant and tightly controlled both internally and externally.

Cleanroom environments are a crucial area for the process and manufacture of pharmaceutical products. Cleanrooms are controlled and maintained using very stringent protocols and guidelines outlined by different organization. To monitor the quality of a room, proper standards have to be established.  Different room classes are necessary for the different production areas as regards the different production steps.

Major Drug Regulatory Agencies World Wide

 Pharmaceutical companies and regulatory agencies work together to enhance patient safety when a medicine is first being studied (pre-approval) and after it becomes available to patients and their health care providers as a treatment option, following authorization by regulatory agencies (post-approval). 

Regulatory agencies are government or non-government authorities, responsible for oversight of the effectiveness, safety, manufacture, and distribution of medicines in a specific country or region of the world such as the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).

Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue guidelines for drug development, licensing, registration, manufacturing, marketing and labeling of pharmaceutical products.

Writing Standard Operating Procedures (SOP)

1.0 Overview

A Standard Operating Procedure (SOP) is a set of written instructions that document a routine or repetitive activity followed by an organization. The development and use of SOPs are an integral part of a successful quality system as it provides individuals with the information to perform a job properly, and facilitates consistency in the quality and integrity of a product or end-result.

 The term “SOP” may not always be appropriate and terms such as protocols, instructions, worksheets, and laboratory operating procedures may also be used. For this document “SOP” will be used. This document is designed to provide guidance in the preparation and use of an SOP within a quality system.

Implementation Of Change Control

Change control is defined as : “A formal system by which qualified representatives of appropriate disciplines review propose or actual changes that might affect a validated status. The intent is to determine the need for action that would ensure and document that the system is maintained in a validated state.”

The implementation of a change control system is an important and necessary step in the validation approach for equipment and facilities. Vital to any change control system is its efficiency in that it does not require too much time and effort to handle changes.

Application Of The F0 Value in Steam Sterilizer

                    The F0 value of a saturated steam sterilisation process is the lethality expressed in terms of the equivalent time in minutes at a temperature of 121 °C delivered by the process to the product in its final container with reference to micro-organisms possessing a Z-value of 10. The total F0 of a process takes account of the heating up and cooling down phases of the cycle and can be calculated by integration of lethal rates with respect to time at discrete temperature intervals. When a steam sterilisation cycle is chosen on the basis of the F0 concept, great care must be taken to ensure that an adequate assurance of sterility is consistently achieved. In addition to validating the process, it may also be necessary to perform continuous, rigorous microbiological monitoring during routine production to demonstrate that the microbiological parameters are within the established tolerances so as to give an SAL of 10^−6 or better. In connection with sterilisation by steam, the Z-value relates the heat resistance of a micro-organism to changes in temperature. 

Basic Check Points Of Autoclave Validation

The success of sterilization is dependent upon the performance reliability of the autoclave. Validation of effectiveness includes monitoring temperature, pressure and cycle duration time for each cycle and providing periodic sterilization/decontamination challenges (quality assurance), i.e. use of biological indicators. A logbook should be maintained to record autoclave use and be available for inspection.