Publisher's Synopsis
The Qualification of facilities and utilities is best managed with the creation of a qualification plan. The plan can provide a framework that outlines the qualification activities, rationales, deliverables, resources and timing. However, certain qualification activities are strongly recommended and mandated by health regulators especially within pharmaceutical biotech, medtech and medical device sectors. The regulatory legislation pertaining to the specific products and markets can inform the essential qualification requirements. Medical devices range in their principle mechanism of action, complexity and intended use. For example, the facility and supporting utilities necessary for the manufacture and packing of a surgical implant differs from an Orthopedic crutch or aid. Yet again, a medicinal product or combination device such as a pre-filled syringe with a biological formulation will require aseptic techniques to be applied during the process. This controlled environment that assures sterility is supported by qualified facilities and utilities that need to function and perform consistently. Therefore, the scope and complexity of C&Q and validations must be designed based on the products manufactured and their intended purposes. With that said, there are a number of keystone commissioning, qualification and validation activities that represent best practices that are broadly applied to meet regulations. The essentials of C&Q can be specified in company (in-house) procedures or standard operating procedures. The discrete requirements required for specific projects can then be guided with the creation of a C&Q plan.
This short pocket book covers the below content.
Table of Contents
Introduction to Commissioning, Qualification And Validation
Overview, High Level understanding C&Q, REGULATORY REQUIREMENTS
C&Q Model, QUALIFICATION Model for Manufacturing systems and Equipment User requirements specification, (URS), Design qualification (DQ)Commissioning, EU GMP V4 Annex 15, Changes to validated systems or processes, Introduction, Validation and product lifecycle, Cleanrooms
Cleanroom Environment, Cleanroom Zoning and Classification, Types of Contamination, Cleanroom Classification TablE, ZONE CLASSIFICATION, HVAC Particulate Control Total Airflow Volumes & Recovery Rates
Particle Generation Rate (PGR)
Room Supply Air Volume Non-unidirectional flow & unidirectional
Unidirectional flow
Airlocks
Room Temperature and Relative Humidity
Temperature
Control and Spread of Smoke
CLEANING
HVAC Systems
ISO Standards for Cleanrooms
Temperature
Air Handling Units
Filtration
course/ PRE- Filtration
Fine / SECONDARY Filtration
Compliance Tests for GMP Zones
Particle count test
FILTER LEAKAGE TESTS
CONTAINMENT LEAKAGE TEST
AND MORE
