quality or compliance no deviation

Quality or Compliance?

Just starting out in the pharmaceutical industry or an industry veteran who still has some confusion around these two terms? Let’s look at some fundamentals!

There could be a dizzying amount of regulations and terms in the pharma industry. Even for me, who’s been here for more than 15 years, I still find myself learning new terms and gaining knowledge on a daily basis. This is due to:

  • the enormous numbers of dosage forms, manufacturing processes, critical aspects around product lifecycle, and technologies evolving constantly, and also
  • the evolving regulation requirements, in sync with science and technology.

However, regardless of the complexity of technologies and regulations, there’s only one ultimate target for everyone – to assure patient safety by delivering medicine with the required quality, safety and efficacy.

Quality focuses on medicinal products meeting the pre-defined specifications (e.g. physical, chemical and microbiological specifications) throughout the whole shelf life. The quality of medicines is achieved through controls defined in GxPs and more.

Safety is to ensure any potential risks like carcinogenicity, genotoxicity and reprotoxicity are uncovered and well understood.

Efficacy provides the patients with the right strength of medicine to be effective, yet not toxic.

To achieve the above, health authorities, together with professional organisations (e.g. ISO), have been developing requirements, guidance and standards to regulate and guide the industry, hence, to safeguard the patients. When medicine manufacturers establish and execute their policies and procedures in accordance with those regulatory requirements, guidance and consensus standards, they are in compliance.

While the terms ‘quality’ and ‘compliance’ are sometimes used interchangeably, there’s a significant difference.

Quality beyond compliance

The regulatory requirements are established for the whole industry with various technology and experience levels. They often lay down the minimum requirements in order to achieve product quality, and without implementing those measures you can barely achieve product quality consistently.

Hence we always say: Quality beyond Compliance – if we aim to achieve product quality, compliance comes naturally.

Know our roles

Not all of us hold a role in Quality or Compliance, but we are all contributing to quality and compliance. You might not be able to cite all the regulations, but an awareness of the GxP or regulatory requirements applicable to your job is necessary. With various roles and responsibilities, we should understand how our roles impact product quality and what is required for our roles to achieve quality and to maintain compliance.

The organisation’s position

Each individual piece of work we perform is built on the foundation of the Quality System. It is our PQS (Pharmaceutical Quality System) that ensures the personnel are trained and qualified, ensures that any risk to product quality is managed, and so much more. Though the PQS is owned by the quality department, senior management is ultimately responsible for:

  •   Ensuring an effective PQS is in place,
  •   Ensuring adequate resources are assigned, and
  •   Ensuring roles, responsibilities and authorities are defined, communicated, and implemented throughout the organisation.

On this journey, the commitment to quality and the establishment of a quality culture starts from the top management and is shared by everyone in the organisation.

At No deviation, we partner with you to help you build the quality in your product. Reach out to us to know how we can help you achieve, retain, and regain cGMP compliance.

You can also visit our website for more information on our services.