Pharma, Pharmaceutics and Biotechnology Conference

This is a critical component in a drug development program since pharmaceutical manufacturing involves assuring quality, safety, and efficacy of pharmaceutical products. In this session, the technological, process, and regulatory aspects that detail drug manufacture will be addressed. Thus, the good manufacturing practice process begins with raw material selection and preparation, which includes APIs and excipients. The raw materials of safety and efficacy for the drug administered are of high purity and quality.

The manufacturing environment too, needs to have a high standard of cleanness and sterility to ensure that no contaminates may enter the product. MPs are the norms on which pharmaceutical manufacture is based. The FDA, EMA and similar agencies have rules that have created quality assurance protocols. These ensure uniform products that meet the required standards. Compliance with GMP said to include a lot of documentation, proper training of personnel, and quality control at all manufacturing stages.

Examples of different manufacturing processes are in this regard: such as batch production, continuous manufacturing techniques, and sterile manufacturing techniques, among others. All these are attached with different demands and considerations. Sterile manufacturing would thusly come with various requirements for environments and procedures concerning risk minimization related to contamination - particularly injectable and biologics. Another critical aspect of drug manufacturing is process validation.

This is validation that manufacturing processes carried out in a controlled environment, under uniform conditions, recurrently produce products meeting predetermined quality criteria. Validation in this regard assures that equipment, processes, and systems utilized in the manufacturing process are performing according to design specifications in order to yield safe and effective products.

Quality control is testing of raw materials, in-process, and finished pharmaceutical products. It ensures that every batch reaches the market with standard specifications in regard to identity, strength, quality, and purity.

In fact, supply chain management is very important for any pharmaceutical manufacturer. Proper management of the supply chain will ensure a steady supply of raw materials, scheduling of production, and successful delivery of the product to healthcare providers and patients.

It will cover the pharmaceutical manufacturing landscape, the most important enabling technologies, regulatory considerations, and quality assurance practices that set the basis of successful pharmaceutical product production.

The participants will understand the key challenges and innovations driving the future of pharmaceutical manufacturing development.