• July 14, 2024

The pharmaceutical manufacturing process includes critical processes for discovering, developing and manufacturing drugs to cure the patients of respective illnesses. There are various forms of drugs, and selection for patients depends on various factors such as the disease’s nature, the patient’s ability to absorb a particular state, environmental conditions, and many others.

The pharmaceutical manufacturing process is performed by various departments, which work synchronously with each other. If they do not work synchronously, it will disturb the pharmaceutical manufacturing process and can deviate the drug’s critical parameters from standard values.

Such products must be destroyed instead of sending them for distribution. Otherwise, regulatory bodies will punish the drug manufacturer and can even shut down the manufacturing operations.

The pharmaceutical manufacturing process also involves the distribution of manufactured drugs. The drugs are distributed to their end-users through various channels, including pharmacies, hospitals, government bodies and health insurance organizations.

 

Pharmaceutical manufacturing process

 

Pharmaceutical manufacturing process approval and accreditation

Any manufacturer who wants to start the pharmaceutical manufacturing process must get approval from relevant regulatory authorities in that market. Without such permission, any manufacturer cannot start manufacturing pharma products. If any manufacturer starts producing drugs without prior approval, these drugs are considered illegal and are subject to actions according to laws.

Every regulatory body has a different procedure for approval, although requirements remain the same. The manufacturer should prove the fulfilment of all the resources, such as equipment, testing facilities, and resources for the safe drug manufacturing.

When getting approval, it is necessary to get approval for every drug. Getting approval for one drug does not mean that other drugs can also be manufactured. Additionally, regulatory bodies must approve every new facility or factory before starting manufacturing operations.

Types of Pharmaceuticals manufacturing process

The pharmaceutical manufacturing process has three main categories according to their roles in the pharma product life cycle. A pharma company may involve all these processes or might only have one of these functions. It depends on their facilities and capabilities.

Generally, the pharmaceutical manufacturing process can be categorized according to the following

  • Mainline
  • Research and Development
  • Generic

Mainline Companies

Mainline pharma companies are said to have their research and development facilities. They also have a manufacturing plant, which they use to manufacture their researched products after getting approval from regulatory bodies.

When a mainline company discovers a new drug, the company files a patent for that particular product. The company is protected with patent protection which forbids any other company from manufacturing the product.

After the protection period is passed, any manufacturer can produce these products after getting approval from regulatory bodies.

These pharma companies are often backed up with large-scale financial support, and their manufacturing plants are located at more than one location, sometimes worldwide. Facilities for Research and Development are dedicated, and separate facilities are used for manufacturing purposes.

Research and Development Companies

Research and development companies do not have approved drugs for manufacturing or marketing. They provide facilities to other drug manufacturers for research purposes.

They often act as sub-contractors to provide support to other manufacturers.

Generic

Generic pharma companies manufacture products no longer protected by patent protection. The products do not require research or manufacturing method development. Their formulation is pre-developed, with proven clinical trial results.

Generic companies produce the products at a lower cost than it was by the patented manufacturer. Common examples of Pharmaceutical manufacturing process include packaging, water treatment plant and tablet compression.

 

Pharmaceutical manufacturing process regulations

The pharmaceutical manufacturing process is one of the most highly regulated industries in the world, and they are obliged to adhere to the regulatory body’s guidelines. Without prior approval from regulatory bodies, any pharma manufacturer cannot develop, produce or sell the pharmaceutical product.

When a pharmaceutical manufacturer desires to start its operation, it must first get approval from the respective regulatory body regulating that particular market. Regulatory approval is also required every time the manufacturer plans to launch a new product. The scope of requirements for every market or regulatory body is defined individually by each regulatory market.

Every country is regulated by its relevant regulatory body that controls that particular drug market. A pharma manufacturer must fulfil all criteria related to its relevant regulatory body.

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 the markets in the United States. Every pharma manufacturer that plans to manufacture or market any pharma product must follow all the regulations.

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 the 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 product is a broad term that can take many forms, primarily focusing on the well-being of humans. There can be different criteria for their classification. In this article, we adopt the Federal Food, Drug, and Cosmetic Act (FD&C Act)

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

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