Pharmaceutical manufacturing process

The pharmaceutical manufacturing process includes critical processes for discovering, developing and manufacturing drugs.

Pharmaceutical manufacturing processes is a joint functionality of various sections. Each section has a distinct and definite function to process raw material until it transitions into finished form. The combined working and harmony among different sections is necessary to prevent disturbance in manufacturing process and deviation in the product’s parameter

f any drug manufacturers does not follows the standard manufacturing process, it will result in product recall and regulatory actions.

Another critical aspect of the pharmaceutical manufacturing process is product distribution. It involves a series of transportation and logistics to distribute drugs to their end-users through pharmacies, hospitals, government bodies and health insurance organizations.

Pharmaceutical manufacturing process approval and accreditation

Any manufacturer who wants to enter into the pharma business must get approval from relevant regulatory authorities. Without such permission, any manufacturer cannot start manufacturing pharma products; doing so could result in strict legal actions and product confiscation

Every regulatory body has a different procedure for approval, although requirements remain the same. The manufacturer should apply all those requirements, such as equipment, laboratory, resources, and areas, in their manufacturing facility.

Getting approval for one drug does not mean approval for other drugs and must be obtained for every single drug type. Similarly, approval for a manufacturing facility is also necessary before starting manufacturing operations.

Types of Pharmaceuticals manufacturing process

The pharmaceutical manufacturing process is generally divided into three main categories. A pharma organization can choose to be only one type, or can include all three functions in their business operations, and includes the following.

• Mainline
• Research and Development
• Generic

Mainline Companies

Mainline pharma companies have their R&D facility and manufacturing. They use manufacturing facility to commercially produce the drug they discovered .

When a mainline company discovers a new drug, it files a patent. The patent protects the company by preventing its competitors from manufacturing the product. A timeline protects the patent, and any manufacturer can manufacture the patented product after the protection period has passed.

Mainline pharma companies are often backed up by heavy financial support, and their manufacturing sites are located at multiple locations. R&D facilities are separate from the manufacturing facilities.

Research and Development Companies

Research and development companies are only allowed to perform R&D, and cannot manufacture or market their drug products. They are only allowed to provide R&D facilities to other drug manufacturers and act as sub – contractors

Generic

Generic pharma companies manufacture products no longer protected by patents . The products have established R&D  facilities, and their formulation is pre-developed, with proven clinical trial results.

Generic companies produce the products at a lower cost as compared to the patented drug.

Pharmaceutical manufacturing process regulations

The pharmaceutical manufacturer is obliged to adhere to the regulatory body’s guidelines. Without prior approval from regulatory bodies, pharma manufacturer cannot develop, produce or sell the pharmaceutical product.

Every country is regulated by its relevant regulatory body that controls the manufacturing and marketing of drugs in that particular region or country. Some important regulatory bodies around the world are as follows.

• US Food and Drug Administration (FDA)
• The European Medicines Agency (EMA)
• The Japanese Pharmaceutical and Medical Devices Agency (PMDA)

US Food and Drug Administration (FDA)

The United States FDA is the regulatory body for pharma products in the United States. The FDA enforces two types of regulations – the Federal Food, Drug, and Cosmetic Act (FD&C) and Section 361 of the Public Health Service Act.

The FD&C Act deals with traditional drugs, while the PHS Act deals with biological products.

The European Medicines Agency (EMA)

The European Medicines Agency (EMA) is responsible for drug regulation in the European Union. It regulates medicinal products used for both humans and animals, including biologics.

The Japanese Pharmaceutical and Medical Devices Agency (PMDA)

The Pharmaceuticals and Medical Devices Agency is responsible for the safety and quality of medical drugs and devices. It is the equivalent of the US FDA.

Common functions of PMDA include Drug and Medical device testing, Post Market Drug Safety and Victim Compensation.

Types of pharma products in the pharmaceutical manufacturing process

The pharmaceutical manufacturing process can take many forms. According to FD&C Act, pharmaceutical products are primarily divided into Drug, Device, and Biological products. The definition of drug and device is described in sections 201(g) and 201(h) of the FD&C act. If any product fulfils the requirements described in these definitions, they are officially classified as a Drug or Device.

Drug

According to section 201(g)

• Product recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary.
• Product intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals
• Product (other than food) intended to affect the structure or any function of the body of man or other animals.

Medical Device

According to section 201(h), a device is a an instrument, apparatus, machine, implant or another similar object that

• Recognized in the official National Formulary or the United States Pharmacopeia.
• For use in the diagnosis of disease or in the cure, mitigation, treatment, or prevention of disease in humans or animals
• That affects the structure or any function of any body of humans or animals.

Biological Products

The biological products are defined in section 351(i) of the Public Health Service Act. Any product that fulfils the following requirement is licensed under PHS Act as a Biological Product.

• A virus
• Therapeutic serum
• Toxin
• Vaccine
• Blood, blood component or its derivative
• Allergic product
• Protein or its analogous
• Arsphenamine or its derivative