What is TRS in WHO?
The WHO Technical Report Series (TRS) makes available the findings of various international groups of experts that provide WHO with the latest scientific and technical advice on a broad range of medical and public health subjects.
Which guidelines is useful during pharmaceutical technology transfer?
Following documents should be prepared during the successful tech transfer.
- Technology transfer protocol.
- Facility qualification protocol and report.
- Equipment qualification protocol and report.
- Process validation protocol and report.
- Cleaning validation protocol and report.
What are the tools that control and monitor quality of work in the pharmaceutical industry?
Various frameworks and methods, such as quality by design (QbD), real time release test (RTRT), and continuous process verification (CPV), have been introduced to improve drug product quality in the pharmaceutical industry.
What are the functions of quality control laboratory?
Quality control (QC) is one of the most important impacts on laboratory testing—it ensures both precision and accuracy of patient sample results. The integrity of quality control samples is important to both management of overall quality as well as to meeting requirements of proficiency testing.
WHO TRS 937 process validation?
Non-sterile process validation as per WHO Technical Report Series, No. 937. Process validation provides documented evidence that a process is capable of reliably and repeatedly rendering a product of the required quality.
WHO is TRS 981?
Annex 2 of the new Technical Report 981 is a new WHO guideline on the implementation of a quality risk management system. The aim of this guideline is to assist the implementation of a QRM system, covering activities such as development, manufacturing, sourcing of materials, testing, packaging and storage.
What is SU and RU in technology transfer?
Regulatory requirements in the countries of the sending unit (SU), or manufacturing plant transferring the technology, and the receiving unit (RU), or manufacturing plant receiving the tech transfer, and in any countries where the product is intended to be supplied, should be taken into account.
What is the basic requirement of technology transfer?
The basic requirements of Technology Transfer are: Quality Risk Management (QRM) Documented approach. Logical approach. Skilled and trained staff.
What is QC in pharma?
Quality Control (QC) is the group that performs the actual testing on raw materials, as well as final products. They execute the analysis of chemical batches or medical devices, testing samples and compiling the performance data.
What is in-process quality control?
Summary. In-process quality control allows the producer to follow all changes that occur during applied technological procedures. It gives the producer security that the finished product fulfills all quality requirements, most of all that the product should be safe.
Who introduced rules for quality control in laboratory?
It is a chart in which the data from a quality control are plotted and from which visually we can find out whether a particular laboratory test is working or not. The name of the chart is given after Stanley Levey and Εlmer R. Jennings who first introduced this chart in the 1950s.
How to validate the water system?
Before starting the validation, water system qualification should be completed i.e. design qualification (DQ), installation qualification (IQ) and operational qualification (OQ). Water sampling and testing should be done for 2 to 4 weeks to monitor the water system. During this phase, water system should operate continuously without failure.
What is pharmaceutical water treatment system validation?
Pharmaceutical water treatment system validation consists of three steps which are: DQ (Design Qualification) IQ (Installation Qualification) OQ (Operational Qualification) & PQ (Performance Qualification) 1. It includes all the information about various components of water treatment system.
What are the phases of purified water system validation?
Purified Water System Validation. Commissioning, qualification, first, second and third phases of validation, their documentation and sampling schedule in purified water system validation. Water system validation (generation and distribution) should contain three phases: Phase I: investigation phase; Phase II: short-term control;
How to qualify a water system?
Hence, it should be validated. Before starting the validation, water system qualification should be completed i.e. design qualification (DQ), installation qualification (IQ) and operational qualification (OQ). Water sampling and testing should be done for 2 to 4 weeks to monitor the water system.