Tag: Process Validation

concurrent release of PPQ batches Pharma process validation

Process validation and aspects of concurrent release of Process Performance Qualification PPQ batches. Validation in pharmaceutical manufacturing and any of the process carried out in its process is very important factor as mentioned in current good manufacturing practices guidelines and in the guidelines on process validation published by US FDA in Jan 2011, drug manufactured […]

Terms used in pharma validations and their definitions

Process validation terminology and definitions Capability of a process: Ability of a process to produce a product that will fulfill the requirements of that product. The concept of process capability can also be defined in statistical terms. (ISO 9000:2005) Commercial manufacturing process: The manufacturing process resulting in commercial product (i.e., drug that is marketed, distributed, […]

Analytical Methodology Process validation aspects

Validation and approach towards analytical Methodology Pharmaceutical manufacturing process knowledge depends on accurate and precise measuring techniques used to test and examine the quality of drug components, in-process materials, and finished drug products. Validated analytical methods are not necessarily required during product- and process-development activities or when used in characterization studies and during process validation. […]

Continued Process Verification Process Validation Stage 3

Pharma Process validation,aspects of continued process verification Continued process verification: can be defined as assuring that during routine pharma production the manufacturing and other processes remains in complete state of control. Pharmaceutical manufacturing process are required to be validated so as to comply with the requirements of current good manufacturing guidelines on process validation published […]

Process Validation Process Qualification Process Performance Qualification PPQ guidelines Process Validation

Process Qualification and Process Performance Qualification (PPQ)Current Good manufacturing  guidelines for Process Validation (Stage 2 in process validation) Process validation and aspects of Process Qualification and Process Performance Qualification (PPQ) c gmp guidelines During the process qualification (PQ) stage of process validation, the process design is evaluated to determine if it is capable of reproducible commercial […]

Process Design and Process Validation Recommendations

Process Validation Recommendations for Process Design Process Design In pharmaceutical manufacturing process design is the activity of defining the commercial manufacturing process that will be reflected in planned master production and control records. The goal of this stage is to design a process suitable for routine commercial manufacturing that can consistently deliver a product that […]

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