Pharma Blog
FDA Clinical Study Requirements for IND
Clinical study requirements for an Investigational New Drug (IND) application are designed to ensure the safety and efficacy of the investigational drug during human trials. Here are the key aspects and requirements: Clinical Study Protocol A detailed clinical study protocol must be included in the IND application. This protocol should ... Read More
Administrative Modules and Submission of IND Application
The administrative module of an IND application includes essential forms and information that provide the FDA with details about the sponsor, the investigational drug, and the proposed clinical trials. Key components include: Submission The submission of an IND application involves several steps to ensure that the FDA receives all necessary ... Read More
Types and Components of Investigational New Drugs (IND) Application
An Investigational New Drug (IND) application is a request for authorization from the FDA to administer an investigational drug or biological product to humans. This application must be authorized before the interstate shipment and administration of any new drug or biological product that is not the subject of an approved ... Read More
SOP for Change Control in Pharmaceutical Industry
1.0 OBJECTIVE To lay down a procedure for Change Control. 2.0 SCOPE The SOP is applicable to any change in the documentation and facility required to be carried out to make amendments, rectify errors, improvements, meet regulatory/ statutory/ legal requirements. It shall be applicable to all Departments at XYZ pharm. ... Read More
Vulnerabilities of the Global Supply Chains of Medicine
The availability of medicines has been a longstanding concern in the EU. The root causes of shortages are multifactorial, with challenges identified along the entire pharmaceutical value chain, from quality and manufacturing problems to industry’s competitiveness. In particular, shortages of medicines can result from supply chain disruptions and vulnerabilities affecting ... Read More
An Overview of Supply Chain Management in Pharmaceutical Industry
Supply chain management is the successful management and planning of all supply chain activities that take place in a business. This can include logistics, sourcing and product development. Its aim to gain competitive advantages and customer satisfaction with better use of assets and resources. The coordination of daily information about ... Read More
Quality Plan for a Product or Service Realization
The product and service provision planning process defines the following controls, as appropriate to the product. This plan is sometimes called a quality plan. The quality objectives and regulations The necessary processes, documents and resources The required checks and criteria for product acceptance The records needed Planning also leads into ... Read More
Foundational Principles of ICH GCP
Let’s delve into the fundamental principles that shape the ethical conduct of clinical trials according to ICH Good Clinical Practice (GCP): Ethical Foundation: Clinical trials must align with the ethical principles outlined in the Declaration of Helsinki, ensuring consistency with GCP and relevant regulatory requirements. Balancing Risks and Benefits: Before ... Read More
Diabetes and Foot Care Recommendations
American Diabetes Association (ADA) Standards of Care 2024: 1. Perform a comprehensive foot evaluation at least annually to identify risk factors for ulcers and amputations. 2. The examination should include inspection of the skin, assessment of foot deformities, neurological assessment (10-g monofilament testing with at least one other assessment: pinprick, ... Read More
Insulin Therapy in Type 2 Diabetes
ADA Standards of Care 2024 1. Many adults with type 2 diabetes eventually require and benefit from insulin therapy. The progressive nature of type 2 diabetes should be regularly and objectively explained to individuals with diabetes, and clinicians should avoid using insulin as a threat or describing it as a ... Read More
CAPA Management in FDA Regulated Industry
A CAPA plan is a quality management strategy used in the manufacturing and production industries to identify and rectify defects to ensure they won’t repeat again in the future. Once a CAPA plan is implemented, it must illustrate ten objectives to meet the intent of the FDA 21 CFR 820.100 ... Read More