When it comes to pharmaceutical quality management, finding the right pharmaceutical QMS gets even more important. There are specific aspects of the pharmaceutical industry which are unique in nature and therefore require special focus. If ISO 9001 and GMP were enough, FDA wouldn’t have mentioned ICH Q10 in the FDA guidance document.
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In this blog we will try to narrow it down to 5 specific factors you should consider while choosing your pharmaceutical QMS and no, we will not end up explaining documents, capa, training etc etc, those will be a part of the QMS anyway. So we will rather focus on specific problems which are unique to the pharmaceutical industry. Let’s get started.
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ICH Q10 compliance
Even though FDA mentions ICH Q10 is optional, if FDA mentions something, one can’t ignore that. But what is the need of ICH Q10 when you already have GMP and ISO 9001. The reason ICH Q10 is important is it creates a framework considering the lifecycle of pharmaceuticals products, all of which are not covered in regional GMP of ISO 9001. The typical lifecycle of pharmaceutical are,
- Pharmaceutical Development
- Drug substance development
- Formulation development (including container/closure system)
- Manufacture of investigational products
- Delivery system development (where relevant)
- Manufacturing process development and scale-up
- Analytical method development
- Technology Transfer
- New product transfers during development through manufacturing
- Transfers within or between manufacturing and testing sites for marketed products
- Commercial Manufacturing
- Acquisition and control of materials
- Provision of facilities, utilities, and equipment
- Production (including packaging and labeling)
- Quality control and assurance
- Release
- Storage
- Distribution (excluding wholesaler activities)
- Product Discontinuation
- Retention of documentation
- Sample retention
- Continued product assessment and reporting
So if you have a QMS that can help manage quality for different phases of products, this should be okay. For e.g. Isolocity is a GMP validated QMS, which means it already considers different phases, so even if you add additional phases which are not part of GMP, like development, this should run smoothly.
For e.g. you can have specific quality events for development phases, as you receive the product through acquisition, you can have receiving inspection, for all phases and subphases you can create documents that have a parent child hierarchy.
So in a nutshell, compliance should be your first check mark and if a QMS doesn’t help you comply with GMP, ISO 9001 and ICH Q10, that should not be on your shortlisted QMS list. Did we forget to mention that Isolocity is GMP-validated, ISO 9001 compliant and FDA 21 CFR Part 11 compliant?
2. Integrations
Integration is another important piece of the puzzle. If you follow cGMP, or ISO 9001 or ICH Q10, all of them put a lot of emphasis on documentation. Therefore good integration possibilities for documentation is extremely important. We will shamelessly promote our Isolocity here but as an example. Isolocity offers integrations with Microsoft SharePoint and OneDrive, which most of the organization nowadays use for their documentation.
Integrations for controlled environments are equally important. As a pharmaceutical company, you would need clean rooms, storage areas, proper temperature and humidity control and you would want that data to flow to your QMS. So you should also check if not a built-in integration, if the QMS has the potential of bringing all those data at one single place through an open API.
Related section: Integrations
3. Risk management and Pharmacovigilance
For a pharmaceutical QMS, the risk management aspect has to be really strong. One cannot just afford to have any risk related to pharmaceutical products. So how a QMS can minimize risk and help with pharmacovigilance is extremely important. We know most QMS would have a risk management module too, but in this section we are going to discuss the importance of an advanced risk management module.
So before you move forward with a QMS, you should ask these 2 questions. We will also give hypothetical answers if those questions were asked to us.
Question 1 : How does your QMS handle risk identification and assessment?
Isolocity helps with risk management by integrating PFMEA and HACCP into quality events. PFMEA allows companies to identify and address potential issues early in the manufacturing process, ensuring optimal efficiency and product safety. The PFMEA module facilitates remote risk assessment, reduces contamination, and enhances quality control through automated digital forms and e-signature procedures, minimizing human contact.
Unlike what most people think, HACCP can and should also be used for pharmaceutical companies. Many companies are already using it, mainly because of these 3 reasons:
- Risk Management: HACCP helps identify and control potential hazards at critical stages of pharmaceutical production, including manufacturing, packaging, and storage.
- Process Control: It emphasizes prevention by establishing critical control points (CCPs) and continuous monitoring to maintain product safety and quality.
- Regulatory Compliance: HACCP aligns with GMP and other quality standards, ensuring consistent product quality and meeting regulatory requirements.
Related blog : What are the 7 steps of HACCP?
Question 2 : Does your QMS comply with regulatory requirements for risk management?
Isolocity’s QMS is designed to comply with regulatory requirements for risk management, including ISO 31000 and FDA guidelines. Here’s how:
ISO 31000 Compliance:
Risk Management Framework: Isolocity provides tools for establishing a structured risk management framework that integrates seamlessly with your organization’s processes. This includes creating, maintaining, and improving a risk-aware culture.
Comprehensive Risk Management Process: Our platform supports the full risk management process, from risk identification and assessment to risk treatment and monitoring. Customizable templates and automated risk scoring ensure thorough and consistent risk evaluations.
FDA Compliance:
Good Manufacturing Practice (GMP): Isolocity helps you adhere to GMP requirements by offering features for documenting and controlling all quality management processes. This includes detailed risk management protocols, process validation, and quality control measures.
Pharmacovigilance: Our software supports pharmacovigilance activities by automating the collection, analysis, and reporting of adverse drug reactions (check the integration section mentioned above). This ensures compliance with FDA guidelines for drug safety monitoring and risk mitigation.
Isolocity is also FDA 21 CFR Part 11 compliant, i.e. electronic records and signatures on Isolocity are regarded as reliable and equivalent to paper records.
Conclusion:
So we know it has been a detailed discussion, so let us conclude for a quick summary and you can get on with your life.
When selecting a pharmaceutical QMS, it is essential to consider the following 3 key factors:
- Compliance: Ensure the QMS supports GMP, ISO 9001, and ICH Q10 standards. Isolocity meets these requirements, managing quality across all product lifecycle phases.
- Integrations: Look for strong integration capabilities for documentation and environmental control. Isolocity integrates with Microsoft SharePoint, OneDrive, and supports open API for seamless data flow.
- Risk Management and Pharmacovigilance: Choose a QMS with advanced risk management and pharmacovigilance modules. Isolocity integrates PFMEA and HACCP, automating the collection, analysis, and reporting of adverse drug reactions, ensuring regulatory compliance.
Isolocity’s comprehensive compliance, integration, and risk management features make it an ideal choice for pharmaceutical quality management.
In case you are looking for a pharmaceutical QMS, we would love to hear. Just schedule a meeting with us and we will chat.
