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Manufacturing Pharmaceutical Company

The manufacturing of pharmaceutical products has to be maintained at high standards to ensure the strength of the active ingredients, quality and purity of the final products. These standards ensure safe and effective products for patients. Minute changes in any of these factors can have serious consequences for patients, therefore the controls and checks put in place need to be far more stringent than, for example, the food industry.

The medical profession and patients expect medicines to be consistently produced to a high level of precision and safety with every new batch. But it is virtually impossible for the medical or pharmacy professional, much less the consumer, to tell if a pharmaceutical product as supplied by the manufacturer is safe, or if it contains what it is supposed to contain.

The major burden for ensuring consumer safety, lies firmly at the manufacturing stage, where it is essential to use industry-accepted Good Practices to maintain safety and efficacy.

Good Practices for Drug Manufacturing

Both regulatory authorities and Pharmaceutical industry itself puts great emphasis on manufacturing pharmaceutical products using practices and processes that ensure high levels of quality and safety built into every step.

Regulatory requirements emphasise Good Practices for controlling quality and safety, from drug development to distribution:

• Drug discovery: Good Laboratory Practice;
• Drug trials: Good Clinical Practice;
• Manufacturer: Good Manufacturing Practice;
• Distribution: Good Distribution Practice;
• Storage: Good Storage Practice.

Before starting a pharmaceutical manufacturing unit, one should have basic knowledge about manufacturing in the pharmaceutical sector, and/or he should be in partnership with persons who have good knowledge of manufacturing and analytical procedures. Without having basic knowledge of manufacturing, it is difficult to compete or survive even after investing a huge amount.

Searching for premises is also a crucial step in manufacturing unit set- up. Location and building should compile with Good Manufacturing Practice (GMP) standards. GMP standards and plant specifications may slightly vary depend upon country policy and requirements.

Space and Area Required

The manufacturing plant should have adequate space for:-

• receiving and storing raw material;
• manufacturing process areas;
• quality control section;
• finished goods store;
• office;
• rejected goods/drugs store.

Different sections require different criteria for space and requirements. Below is a list of the minimum area required for each section set-up for pharmaceutical manufacturing unit.

Requirements:

• premises, building and plant as per GMP standards;
• constitution of firm and/or company;
• section wise partition in plant;
• technical persons (manufacturing chemist and analytical chemist);
• machinery and laboratory equipments;
• HVAC unit;
• workers and supervisors;
• list of medicines to be manufactured;
• NOC from required departments, whichever is applicable, such as a pollution board;
• manufacturing license and distribution license;
• registration of factory under factory act;
• raw material suppliers;
• packaging material suppliers;
• distributors and/or marketing companies for output consumption.

Licenses:

A manufacturing unit may require different types of licenses and registrations depending on location and country. The most important license for setting up pharmaceutical manufacturing unit is the Manufacturing License.

Below is a list of generally required licenses:

• Company Registration;
• Drug Manufacturing License;
• Drug Distribution License (For Distributing finished goods);
• Testing Laboratory License;
• Good and Service Tax (GST) or any Tax registration required in the country concerned;
• NOC from other departments if required.