Life is a Journey..how to make the best of it!

BayBiotech.NET As per definition of Office of Health and Safety, “containment" is a term used for describing safe methods for managing infectious materials in the laboratory environment where they are being handled or maintained. The main objective of containment is to reduce or eliminate exposure of laboratory workers, other persons, and the outside environment to potentially hazardous agents. Two levels of containment defined are Primary and Secondary containment. Whereas, primary containment refers to the protection of personnel and the immediate laboratory environment from the infectious agents, the secondary containment refers to the protection of the environment external to the laboratory from the exposure to the infectious agent/ material. Primary containment is provided by good microbiological techniques and use of appropriate safety equipments. Secondary containment is provided mainly by a combination of facility design and operational procedures. A combination of ri

The legislation on the Medical Device User Fee Amendments of 2007 (MDUFA), is part of a larger bill — the Food and Drug Administration Amendments Act of 2007 (H.R. 3850) and according to this, a substantial reduction for all existing application fees have been proposed, while providing for new types of medical device user fees. The new user fees are proposed for: • Submission of a 30-day notice. • Submission of a 513(g) request for classification information. • An annual fee for periodic reporting on a class III device. • An annual fee for the registration of a medical device establishment that is a manufacturer, a single-use device reprocessor, or a specification developer. On the other hand all existing application fees are substantially reduced for PMA, Panel-track PMA Supplement, BLA Efficacy Supplement, as well as 510(k) Notification remarkably for small businesses in a range between -18 – 70%. Follow this link to read more on this: Medical Device User Fees Have Been Re

BayBiotech.NET A premarket notification from a manufacturer must include either a summary of the 510(k) safety and effectiveness information of the product upon which the substantial-equivalence determination is based or a statement that this information will be made available by the 510(k) applicant to any person within 30 days of a written request. As per FDA definition, these are the definition of Summary and Statements: Summaries are released by FDA regarding a 510(k) clearance when requested under the Freedom of Information (FOI) Act whereas Statements are used to arrange for this FOI request to be fulfilled by the 510(k) applicant. 510(k) Summaries: If a summary is included, it must be submitted with the 510(k) notification as per FDA guidelines. The summary must be complete and correct in order for FDA to complete its review of a 510(k) submission. FDA will accept summaries and amendments until it issues a determination of substantial equivalence. If a summary has be

BayBiotech.NET Protected Health Information or individually identifiable health information relates to the data about demographics, individual’s past, present or future physical or mental health or condition, provision of health care to the individual, or the past, present, or future payment for the provision of health care to the individual. Individually identifiable health information includes many common identifiers such as name, address, birth date and social security number. A covered entity (health plan, a health care clearinghouse, or a health care provider) must obtain the individual’s written authorization for any use or disclosure of protected health information that is not for treatment, payment or health care operations or otherwise permitted or required by the Privacy Rule. Principle of “Minimum Necessary” Use and Disclosure Principle of “Minimum Necessary” is the central aspect of the privacy rule. Under this principle, it is expected that a reasonable effort mu

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