Life sciences companies are increasingly adopting a global approach to product development. This means that products are designed, manufactured, and tested at different locations around the world. In order to meet regulatory requirements and ensure quality standards are met, it is essential that the company establishes a robust quality management for life sciences that covers all stages of product development.
It is essential to understand the regulatory requirements of quality management for life sciences
The FDA has published a number of documents related to quality management systems in the life sciences industry, including:
- Guidance for Industry: Quality System Regulation for Medical Devices (GUIDANCE). This guidance describes the agency’s expectations for medical device manufacturers’ quality systems. This guide also recommends practices for compliance with 21 CFR Part 820 (Quality Systems Regulation).
- Guidance for Industry: Quality System Regulation — A Guidebook for Clinical Trials of Medical Devices (GUIDANCE 2). This guidebook provides an overview of key concepts and principles in quality system regulation pertaining specifically to clinical trials involving medical devices.
- Guidance on General Principles of Process Validation (GPPV). This guidance describes general principles that should be followed when validating manufacturing processes used in making drugs or biologics
You should have a clear understanding of the specifications for your products, including their composition and functionality.
Specifications are important because they define what quality means in each context of use. For example, if you’re developing new drugs to treat cancer or other diseases, you’ll want to be sure they meet certain standards before releasing them into clinical trials or selling them commercially.
For example, A pharmaceutical company may develop a new treatment for heart disease by combining two existing drugs with slightly different mechanisms of action (MOA). The MOA is one way we can classify drugs according to their function. For example, antihistamines work against histamines whereas diuretics cause increased excretion of sodium from the body by increasing urine production.
You must ensure that you are keeping good records during the whole process.
This is important because it will help you to improve your processes, reduce waste, and meet regulatory requirements.
- Keep records of all raw materials used in production. These include chemicals and biological materials such as cell lines or antibodies. Record their source (where they came from), batch numbers and expiration dates where applicable, quantity used in each production batch (or lot), final concentration/activity levels if applicable (see below), storage conditions at various stages before use (e.g., refrigerated vs room temperature).
- Keep records of all analytical results obtained during manufacture: these may include absorbance measurements taken after centrifugation or gel electrophoresis; quantification by spectrophotometry; purity/impurity analysis by HPLC/LC-MS etc.
- Record details about each step involved in producing your product including equipment used e.g., incubator vs shaker flask; reagent concentrations at various steps e.g., lysis buffer 1% Triton X 100 instead 0 .5% Triton X 100, etc.
You need to follow analytical procedures throughout the development process to ensure that your product meets all quality specifications.
Analytical methods determine the quality and purity of a product or ingredient, as well as its identity and strength.
Analytical methods can be expensive and time-consuming, so it’s important to choose the right method for each analysis. When choosing an analytical procedure, consider:
- The intended use for your product (e.g., whether it will be used for research or clinical trials)
- Whether there are regulatory requirements regarding testing methods (e.g., Good Manufacturing Practices Regulations in Canada)
Keep your system audit ready, might come in handy if audited by an external agency such as the FDA
In order to ensure compliance with regulations and industry standards, it is also important to document all documents produced during the course of your work. This includes:
- Records of decisions made on each project or task (including why they were made)
- Copies of any changes made during testing or production runs
- Any deviations from procedures that were taken by employees (e.g., if someone skipped step 3B because they thought it was unnecessary)
We strongly suggest using document management software for this purpose, while implementing make sure the software comes with automated audit trails.
To follow all the above-mentioned processes, it is essential you have cloud-based software for quality management for life sciences
There are many solutions available, but you should finalize your QMS based on the following features,
- Should be compliant with ISO 13485:2016 & ISO 9001:2015
- The system should focus on automation, you should be able to automate most of your manual tasks
- If you are based out of Canada, the software should be GMP validated
- The software should have all the essential modules of a standard cloud-based quality management software
- The customer support team should be extremely efficient, you will need them more often than you think
- The software should have an uptime of 99% and above
In conclusion, we can say that quality management is a crucial part of product development in the life sciences industry. It is essential to establish a robust quality management system that meets local regulatory requirements. This will help your company achieve its goals while ensuring that all products meet their specifications and are safe for patients worldwide use!