Process Validation

Background of the study: The prime objective of any work in pharmaceutical plant, whether in production or quality control is to manufacture product of requisite quality at the lowest possible cost. Validation is attaining and documentation of sufficient evidence to give reasonable assurance that the process under consideration does and what it purports to do. Methods: In the present study, process validation studies were carried out for a bilayer tablet containing extended release Metformin, Pioglitazone and Glimepiride as per the protocol. The parameters used during the studies were dispensing, sifting, mixing, preparation of granulating solution, granulation, drying and sizing, lubrication (flow property & assay lubricated granules), compression (weight variation, hardness, thickness, friability, content uniformity), labeling and packing. Results and Discussion: The samples collected at different stages were analyzed using UV and HPLC method as per protocol. The results were found to be within the acceptance criteria. Conclusion: From the validation studies carried out, it was observed that no modification was required in present manufacturing process. The method requires further validation only when there is change in raw materials or equipment or process.

Overview
Process validation training activities with a product lifecycle management concept and the FDA risk management framework is critical for the medical device industry, because most of the device failures happen from inadequate processes and poor process control systems. Manufacturers of medical devices must meet the requirements of the Quality System regulation for medical devices (21 CFR part 820). The Quality System regulation at 21 CFR 820.5 states that “each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device manufactured

Proper quality control programs help to control or eliminate manufacturing defects. FDA also believes that incoming material and in-process control validations will assure high quality.

Why Should You Attend
Process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications. Too many processes and too many validations are likely to result in too much time and money wasted in addition to FDA warnings. This webinar teaches you how to minimize process controls and process validations.

Areas Covered in the Session
FDA quality systems requirements
Requirements for design and development planning
Requirements for  process  inputs
Requirements for  process outputs
Requirements for  process design review
Requirements for  process verification
Requirements for  process validation
Packaging and labelling process controls
Requirements for  process changes
Maintenance and inspection of equipment
Control, use, and removal of manufacturing materials
Device master record
Learning Objectives
Learn to minimize the need for process validation
Understand the principles of designing a robust process
Learn to look for advanced warnings of process going out of control
Learn how to prevent process defects for permanently
Who Will Benefit
Senior management
All manufacturing/production managers
Manufacturing and production engineers
Manufacturing supervisors
Quality assurance staff
Regulatory affairs staff
Production operators