Hintlink

cGMP (current Good Manufacturing Practices)

Compliance with good manufacturing practices (GMPs) is mandated by the US FDA and applies to all Pharmaceuticals which are manufactured on-shore or imported into the United States.

A firm can:

Lose valuable time and money
Face seizure of its goods, returns and recalls
Face Warning Letters which are publicly accessible on the FDA website (one and you’re earmarked, two and you’re out)
Face product approval delays
Face regulatory action from the agency if it doesn't adhere to GMPs. This can include huge fines ($m’s) and closure.

You must:

Adhere to cGMP practices from DAY ONE of an operating research or producing facility
Learn how to overcome common documentation obstacles
Improve manufacturing processes and quality control functions
Have an independent QA department
Develop comprehensive validation and calibration programs
Properly maintain facilities and equipment
Construct Quarantine areas for goods in process at various identifiable steps
Identify proven solutions for laboratory controls
Establish and maintain non-conformance programs
Ensure compliance with 21 CFR Part 11
Realise that the top level management of the company is responsible for compliance
Maintain detailed batch records
Hold samples of all components of the product and its containment / packaging
Perform lifetime and stability testing on the product and validate any “sell by” date.

Example:

A product is contained in a bottle. The bottles should be inspected for suitability and contamination, including the material’s chances of contaminating the product itself (especially if plastic). Samples should be swabbed and tested. Samples from each batch should be held in storage. Batch records should be kept and each step of the process should be signed off by QA.

The cap that goes on the bottle should be similarly treated.

Any additional components should be so treated, including inserts such as cotton wool, plastic dispensers, etc.

The product going into the bottle should be manufactured in identifiable batches, with batch records. In essence, continuous production into a storage tank or sorting area is not acceptable as it intermixes product made from different raw material and from different production equipment. Each batch of product should be sampled and tested against a validated assay on calibrated instruments. Primary validation of calibration should be performed on two instruments to prove traceability on a regular basis (minimum annually). Validation should be traceable to NIST standards.

The facility producing the product must conform to a long list of requirements, including hot water in the restrooms and containment against contamination from outside the facility, including rodents, insects, etc.

The filling, closure and labeling of the product must occur under controlled conditions, with batch records and sampling, including held samples.

The final packaging and shipment of batches must be documented and QA’ed.

In short, cGMP is all embracing and doesn’t apply to “special” circumstances or products. It applies equally to OTC and prescription medicines.

We are dependable and experienced partners. Contact us now to add our experience and knowledge to the value that your business delivers.

footer