1. Distilled Water This is produced by vaporizing water and condensing it in a purer state. It is mainly used for preparing reagents but may also be required for other laboratory operations such as rinsing an analyte, transferring a test material as a slurry, as a calibration standard or analytical blank and for cleaning of…
Expiration date: The date placed on the container/labels of an API designating the time during which the API is expected to remain within established shelf-life specifications if stored under defined conditions and after which it should not be used. Retest date: The date when a material should be reexamined to ensure that it is still…
Analytical Laboratory KPIs: Turnaround Time (TAT) Test Completion Rate: Accuracy and Precision: Instrument Uptime: Sample Rejection Rate: Quality Control KPIs: Out-of-Specification (OOS) Rate: Out-of-Trend (OOT) Rate: Deviation Rate: Corrective Action/Preventive Action (CAPA) Effectiveness: Read also: Resource Person: Rajesh Jain
Samples are retained to fulfil two purposes; Reference sample A sample of a batch of starting material, packaging material or finished product which is stored for the purpose of being analysed should the need arise during the shelf life of the batch concerned. Where stability permits, reference samples from critical intermediate stages or intermediates,…
Reagents are an integral part of any laboratory and as such play a vital role in ensuring the validity of analytical results. Reagents must be suitable for the intended use. Consideration should be given to the accompanying documentation and appropriate physico-chemical or biological critical quality attributes for the intended purpose/s. In the laboratory,…
How does FDA interpret the regulations (21CFR part 211) regarding the establishment of expiry dating for chemicals, reagents, solutions, and solvents? Laboratory “reagents, and standard solutions,” as referenced in the CGMP regulations at 21 CFR 211.194, includes laboratory chemicals such as solvents (including mobile phases), dry chemicals (salts, primary standards, etc.), and solutions (#buffers,…
Is parametric release an appropriate control strategy for sterile drug products that are not terminally sterilized? No. Parametric release is only appropriate for terminally sterilized drug products. Although both terminally sterilized and aseptically processed drug product batches are required to meet the sterility test requirement (see 21 CFR 211.167(a)) before release to the market,…
Skip or Periodic Testing Periodic or skip testing is the performance of specified tests at release on pre-selected batches and / or at predetermined intervals, rather than on a batch-to-batch basis with the understanding that those batches not being tested still must meet all acceptance criteria established for that product. This represents a less…
