API Manufacturing Procedure

API manufacturing experts are required to come up with a quality policy. These are generally the

objectives, of the organization. The policy also includes what each department does in terms of duties.

This laydown policy defines the level of quality that the organization should stick to in their operations.

Due to the high level of standardization that API manufacturing companies face, they should;

 Make sure that all their employees are qualified, experienced and that they undergo refresher

courses. These courses make them up to date with frequent technological changes.

 Should incorporate and display proper documentation of their API manufacturing companies.

 Should be updated on technological changes. Should maintain high standard equipment to avoid

low-quality API manufacturing.

 Set up different departments to deals with different roles.

Achieving high standard quality

API manufacturing is a long process. Extra caution should be exercised to avoid contamination between

different active ingredients. Contamination can result to the recalling of the drugs. This in itself spells big

losses to the company considering the time and money spent.

To achieve the best quality, every department should have a quality manager. The personnel should be

highly qualified and experienced. API manufacturing involves the use of raw and packaging materials.

There should be regulations laid down detailing the requirements these items must meet.

Safety needs to be observed in the laboratories as well. Safety gear such as clothing and fire extinguishers

must be provided to the staff. Employees need to be trained about the safety regulations to ensure they

stay out of danger at the API manufacturing site.

Having strict attention to detail skills are not only important but highly paramount. Employees and their

supervisors should carefully note down the measurements of substances used. Such caution enables them

to come up with accurate results.

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