OPERATOR PROTECTION FACTOR (OPF) IN ASEPTIC FACILITY
Introduction:- Class II safety cabinets are designed to control airborne contamination of the product and reduce the exposure of the operator to any airborne contamination…
Tag: Quality Assurance
INVESTIGATING OUT OF SPECIFICATION (OOS) TEST RESULTS FOR PHARMACEUTICAL PRODUCTION
IDENTIFYING AND ASSESSING OOS TEST RESULTS:- FDA regulations require that an investigation be conducted whenever an OOS test result is obtained. The purpose of the…
VALIDATION OF ASEPTIC FILLING PROCEDURE WITH MEDIA FILL
Definition of Media Fill and Requirements of the Guidelines: – According to all guidelines the process simulation with media fill is state of the art…
COMPRESSED AIR TESTING IN PHARMA 1
The Quality of Compressed air is important to ensure that product is safe. The most important parameters in specifying Compressed air quality are: Dew Point…
CLEANING VALIDATION ACCEPTANCE LIMITS FOR PHARMA MANUFACTURING OPERATIONS
DETERMINATION OF CLEANING VALIDATION ACCEPTANCE LIMITS FOR PHARMACEUTICAL MANUFACTURING OPERATIONS Residue Limits:- Validating a cleaning process includes selecting target residues and setting limits for those…
PERSONNEL TRAINING FOR PHARMACEUTICAL INDUSTRY 2
INTRODUCTION:- The pharmaceutical industry is facing a tremendous changes and challenges nowadays. It has been observed that lack of proficient, talented, capable employees has enforced…
HVAC DESIGN FOR PHARMACEUTICAL FACILITIES
In pharmaceutical manufacturing, how space conditions impact the product being made is of primary importance. The pharmaceutical facilities are closely supervised by the U.S. food…
RISK MANAGEMENT METHODS AND TOOLS
The purpose of this annex is to provide a general overview of and references for some of the primary tools that might be used in…
PERSONNEL TRAINING FOR PHARMACEUTICAL INDUSTRY 1
INTRODUCTION: – The pharmaceutical industry is facing a tremendous changes and challenges nowadays. It has been observed that lack of proficient, talented, capable employees has…
COMPRESSED AIR TESTING IN PHARMA
The Quality of Compressed air is important to ensure that product is safe. The most important parameters in specifying Compressed air quality are: Dew Point…
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