Clinical Operations-Design to Execution

Quality Assurance and Compliance: Requirements for Batch Production Records BayBiotech.NET

BayBiotech.NET Batch Production Record is an example of a GMP document and is designed to standardize the process and provides with lot-specific information. GMP Requirements for Batch Records are defined under following FDA regulations:  Master Batch Record 21 CFR 211.188  21 CFR 211.194—Laboratory Records  21 CFR 211.194—Review by the Quality Control Unit A batch production record must be established every time a batch is manufactured and must include the following: Requirements for Laboratory Operations •Establish and follow written procedures for laboratory operations •Use adequate laboratory facilities •Requirements for Laboratory control processes •Methods for testing and examination Requirements for Manufacturing Operations •Establish and follow written procedures for manufacturing operations •Ensure product specifications are consistent •Adequate sanitation principles •Prevent contamination •Appropriate disposition of rejected or unsuitable dietary supple...

BayBiotech.NET Dear All, Happy 2010! I plan to focus on the main components of an informed consent in this blog. Enjoy! Informed consent (21 CFR 50.20, 21 CFR 50.25(a), and 21 CFR 50.25(b)) is a document prepared for the subjects who may be benefited from a clinical trial and provides the key facts about a clinical trial before deciding whether or not to participate. In order to help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant's native language is not English, translation assistance can be provided for them. Main component of an informed consent document are the key details about the study, such as its purpose, duration, required procedures, key contacts as well as risks and potential benefits associated with it. The participant then decides whether or not to sign the consent and participate in the study. Informed consent is not a contract, and the participant may withdraw...