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...

BayBiotech.NET Built environments both residential and non residential are subject to number of indoor air quality (IAQ) and Indoor environment (IE) problems that may cause acute symptoms, health risks or discomfort. A frequent IAQ and IE investigations can determine the occurrence of BRI and provide with healthier work environment. This is of utmost importance for Pharmaceutical/ Life Sciences industry where the product is directly subject to the human usage. Non residential buildings are more prone to BRI as there is a high volume of occupants coming from diverse geographical areas interact in an environment where the ventilation of the building is not directly under the occupants control. Health hazard evaluation teams from the National Institute of Occupational Safety and Health (NIOSH) conducts the investigation upon request and provides with strategies to avoid the recurrence of the problem. Some of the risk factors that may be used to evaluate biological contaminants as pot...

BayBiotech.NET Scope: the policy applies to all research involving human subjects conducted, supported or otherwise subject to regulation by any federal department or agency which takes appropriate administrative action to make the policy applicable to such research. This policy does not affect any state, local or foreign laws or regulations which may otherwise be applicable and which provide additional protections for human subjects. Exclusions:  Research conducted in educational settings, examples: research on education instructional strategies, on comparison among instructional techniques, curricula, or classroom management methods.  Research involving survey procedures, interview procedures or observation of public behavior, unless information is recorded in such a manner that human subjects can be identified.  Research involving the collection of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or...

BayBiotech.NET Pharmacovigilance is a branch that involves the identification and evaluation of safety signals generated by the usage of a medical product. Safety Signal: is a concern raised when excess of adverse events are observed compared to what would be expected with a product's use. Signals can arise from collection of post marketing data, preclinical data and events associated with other products in the same pharmacologic class. Even a single well-documented case report can be viewed as a signal, particularly if the report describes an event that is extremely rare in the absence of drug use. Signals indicate the need for further investigation, which may or may not lead to the conclusion that the product caused the event. After a signal is identified, it should be further assessed to determine whether it represents a potential safety risk and whether other action should be taken. Good Pharmacovigilance Practice is based on acquiring complete data from spontane...

BayBiotech.NET This blog is focused on discussing some of the terminology you may come across while dealing with Quality Control/Assurance or regulatory compliance in a Pharmaceutical/ Life sciences Industry environment. We may not dedicate many blogs on this, but briefly going over them, will provide us the acquaintance with theses terms and may help understand them better whenever they are referenced in other documents/ blogs. These are as follows: Pharmaceutics: discipline of pharmacology that involves evaluation, design and preparation of suitable dosage forms of chemical entities and delivery systems. This discipline is targeted towards optimizing drug action as well as minimizing adverse effects. Pharmaceutics involves studies from interdependent areas such as physical chemistry, biochemistry, analytical chemistry, mathematics, chemical engineering, molecular and cellular biology, pharmacology, anatomy and physiology. Pharmacokinetics: is the study of the time course of d...