Pharma Blog
Purpose of Tablet Coating
Tablets are the most commonly used dosage form which are manufactured in Pharmaceutical Industries. Many tablets in pharma are coated and some tablets are uncoated. Tablet coating is the process where we apply a thin coat of film formers & related excipients over the tablet surface. REASONS FOR TABLET COATING ... Read More
Facility Readiness Goal Date Decisions Under GDUFA
The Generic Drug User Fee Amendments (GDUFA) aim to streamline the approval process for generic drugs, ensuring timely access to affordable medications. A crucial aspect of this process is the Facility Readiness Goal Date Decisions, which influence the FDA’s timelines for reviewing and approving generic drug applications. Key Highlights from ... Read More
FDA Non-Clinical Study Requirements for IND
Non-clinical studies are essential for assessing the safety and biological activity of an investigational drug before it is tested in humans. Here are the key aspects and requirements for non-clinical studies in an IND application: Pharmacology and Toxicology Information Non-clinical studies primarily focus on pharmacology and toxicology to evaluate the ... Read More
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