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API Manufacturing: General Process involved in the manufacture of the APIs.

cGMP (current Good Manufacturing Practice) sets the regulations and guidelines that govern the manufacturing, use and testing of the manufacturing.

Complete hazard assessment tools that allow safe production are available at each stage of the development cycle.

The manufacture of the APIs involves optimally coordinated stages. The process from the raw material to the final product is integrated thus reducing the time taken and therefore the  API manufacturing overheads. It involves varied concurrent procedures although cross -contamination of the different variety of APIs must be avoided. At any development stage, the supporting process required ensuring adherence to the established standards and requirements include:

  • Validation of the process, including cleaning.
  • Release of the batch(s).
  • Analytical method development and validation.
  • Characterization of state properties. To ascertain whether it’s in solid or in other states.
  • Stability studies.
  • API structure proof.
  • Search for any impurities.
  • Preparation of the Analytical Reference Standards.
  • Pharmaceutical writing.
  • Regulatory Filing support.

 

The following are the general processes involved in the manufacture of the API manufacturing.

Check for the incoming goods (Raw Materials).

This is done to ascertain whether the delivery of the raw material is as ordered.

The department tasked with this practice should be totally protected and highly documented to deter any fraud or theft.

 

Storage and material flow logistics such as bar-code and radio-frequency systems are used for proper recording of the goods, thus enhancing flow of the materials and improved safety. This helps reduce costs of purchases hence greater profitability of the industry.

Optimal Laboratory Control.

This entails the laboratory safety which eventually leads to release of high quality products. It also increases efficiency and reduced costs in ensuring compliance with the various set requirements.

Control access of the laboratories and hazard management is done to ensure safe environmental conditions. Totally Integrated Automation enables one to integrate the laboratory with other departments of the AIP manufacturing company.

Preparation of a foundation of desired manufacturing.

This vital process begins from the inspection of raw materials and documentation of sub-processes to ensure efficiency in the production process.

Reaction from the process to the product.

This is a different but very vital process in the API manufacturing. It requires maximum flexibility in automation process. It is the only sure way of running sequential processes and safely meets the high demands and production of quality end product.

Separation and purification for pure active ingredient.

This is done through filtration, crystallization of centrifuging via the individual processes to ensure that any impurities are removed.

Conditioning of the perfect finish.

This is done to ensure that material processes such as particle size, bulk densities and flow properties and packaging of the batches for the subsequent stages are achieved in a reliable manner.

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