Quality Assurance Services
By partnering with us at Apotech, you will receive unparalleled access to our team’s expertise in quality assurance, allowing you to achieve regulatory compliance all along your product's lifecycle.
Ensuring excellence for the Pharma and Biotech industries
Choose Apotech for tailored, high-level support
At Apotech, we understand the importance of maintaining meticulous quality in all pharmaceutical and biotech processes. From research to manufacturing to distribution, prioritising the quality of your products is imperative to meeting your user needs safely.
That’s why we’ve designed our Quality Assurance services around the unique requirements expected of pharma and biotech companies, allowing you to deliver high levels of quality, compliance and efficiency consistently.
Trusted by top-tier teams worldwide
QMS Development
Our comprehensive Quality Management System (QMS) Development services are tailored specifically for the dynamic and highly-regulated pharmaceutical and biotech industry.
We understand the critical importance of maintaining the highest standards in quality, compliance and efficiency within your operations. That’s why our experienced team is dedicated to supporting you in developing robust QMS solutions that ensure regulatory compliance, streamline processes and enhance your overall performance.
Our expertise covers:
- GxP regulation (GCP, GMP, GVP, GLP …)
- EU regulations and standards
- ISO 9001, ISO13485, ISO 22716
- Regulation US FDA 21 CFR
- Other international regulations (Japan, Australia, China and more.)
As part of our QMS Development services, we can offer all – or a selection – of the following services.
Our QMS Development process
1. Needs assessment
- In-depth consultations to identify your organisation's unique quality management requirements, compliance goals and operational challenges.
2. Gap analysis
- Conduct a thorough gap analysis to identify discrepancies between current practices and industry standards/regulations.
- Detailed documentation of identified gaps, laying the foundation for the development process.
3. Authoring documentation and standard operating procedures (SOPs)
- Create clear and concise documentation, including SOPs, to support the QMS.
- We can either author from scratch or remediate your current SOPs
- Documentation designed to facilitate easy understanding, implementation and compliance with industry regulations.
- Implement a tailored QMS framework that integrates seamlessly with your existing processes and systems.
4. Validation and testing
- Perform validation and testing procedures to ensure the QMS functions as intended and complies with regulatory requirements.
- Ensure validation documentation meets industry standards, facilitating smooth audits and inspections.
5. Risk management
- Risk identification and assessment: Employ Quality Risk Management (QRM) with tools like FMEA and HACCP to identify, quantify and prioritise risks impacting critical quality attributes (CQAs) and compliance.
- Risk mitigation: Apply risk control measures aligned with ICH Q9, incorporating CAPA and change control to mitigate risks to acceptable levels, ensuring integration with validation and SOPs.
- Monitoring and review: Conduct continuous risk monitoring and periodic updates to the risk management plan, ensuring alignment with GMP standards through quality audits and management reviews for ongoing compliance and improvement.
6. Training and change management
- Comprehensive training programmes for employees at all levels, ensuring a smooth transition to the new SOPs and QMS.
- Development of change management strategies to address cultural shifts within the organisation.
7. Ongoing support and maintenance
- Provide ongoing support to address any queries or concerns related to the QMS.
- Continuously monitor the QMS to ensure ongoing compliance with evolving regulations and industry standards.
- Perform regular updates and maintenance to keep the QMS aligned with industry best practices and regulatory changes.
- Implement corrective and preventive actions (CAPA) based on performance metrics and feedback.
Qualified Person (QP) Services
Manufacturing Authorisation holders are mandated by law to maintain a continuous presence of at least one Qualified Person (QP). It is the responsibility of the QP to certify batches of medicinal products before they are allowed for sale or use.
At Apotech, we specialise in providing in-country interim QP services for the certification of both commercial products and investigational medicinal products. Our QPs bring extensive experience across diverse biotech and pharmaceutical products, including:
- Tablets and capsules
- Liquids
- Topical
- Sterile
- Biologics
- Advanced Therapy Medicinal Products (ATMPs)
- Blow-Fill-Seal
- PET Radiopharmaceuticals
Responsible Person (RP) services
A Responsible Person (RP) will oversee your QMS, ensuring compliance with Good Distribution Practice (GDP) guidelines and legislation. Our services include training, regulatory support and managing MHRA/EMA inspections in line with the WDA requirements.
It is the responsibility of the RP to:
- Implement and uphold Wholesale Distribution Authorisation, registering with Health Authorities for pharmaceutical product storage and distribution.
- Have experience liaising with regulatory authorities, such as MHRA, EMA and FDA.
- Ensure compliance with GDP Requirements, covering documentation control and all stages of storage and distribution.
- Adhere to EU GDP guidelines and EU/UK Legislation, fulfilling all principal duties and responsibilities of the RP.
- Provide competent authority inspection readiness and GDP auditing.
Mock Inspections
One of our standout services is our mock inspection and inspection readiness programme.
Leveraging our expertise as former employees of the FDA and various national healthcare authorities, we have a unique ability to simulate FDA inspections. This process allows us to identify and address potential issues and concerns before they trigger an FDA Form 483 or FDA Warning Letter.
Our services extend to ensuring FDA inspection readiness through the conduct of mock inspections. These simulations encompass your plant or facility, as well as third-party facilities, vendors/suppliers and contract manufacturers and laboratories.
A mock inspection conducted by our team will prepare you for the intricacies of an actual FDA or other health authority inspection. We can offer guidance on best practices and communication strategies, document and record presentations and task delegation across various facets of the FDA inspection.
Our FDA mock inspections cater to all industries regulated by the FDA, ensuring a comprehensive and thorough preparation process.
The healthcare authorities we have experience performing mock Inspections in include:
- United States: Food and Drug Administration (FDA)
- United Kingdom: Medicines and Healthcare products Regulatory Agency (MHRA)
- European Union: European Medicines Agency (EMA)
- Canada: Health Canada
- Australia: Therapeutic Goods Administration (TGA)
- Switzerland: Swissmedic (Swiss Agency for Therapeutic Products)
- France: ANSM
- Japan: Pharmaceuticals and Medical Devices Agency (PMDA)
- India: Central Drugs Standard Control Organization (CDSCO)
- China: National Medical Products Administration (NMPA)
- Brazil: Agência Nacional de Vigilância Sanitária (ANVISA)
- South Africa: South African Health Products Regulatory Authority (SAHPRA)
- Singapore: Health Sciences Authority (HSA)
Training
Sustained training and perpetual education serve as vital components in ensuring that personnel remain well-versed in the constantly evolving regulatory landscape.
At Apotech, we can provide training in all aspects of quality assurance, including across the GxPs (GCP, GVP, GMP, GDP, GCLP and GLP).
Through our consultants’ expertise in the field, we can employ intervention-based training methodologies that enhance the effectiveness of the imparted training. We can also consider how training might be perceived, offering tailored materials and delivery methods around you.
Using real-world examples, interactive case studies and cutting-edge audio-visual presentation tools, we aim to create an immersive learning experience.
Excited to work together on your next project?
Why choose Apotech’s Quality Assurance services?
Whether you need help establishing your quality management system, conducting a mock inspection, securing a qualified person or implementing a comprehensive training programme, we can help.
With our team’s extensive industry experience, we offer tailored regulatory support and guidance, allowing you to navigate any regulatory requirements with confidence and support at every step.
FAQs
At Apotech, we offer full transparency on our Quality Assurance services. We aim to make the process as simple to understand as possible and are always on hand to answer any questions you might have.
Here are some of the questions we get asked most often.
Yes, we have an amazing team of consultants who work with us to perform local activities such as batch release or authoring SOPs in local languages.
As we understand each country's specificities, we can supply you with the right qualified person, according to the local regulations required.
Featured case studies
GMP QA Consulting
GMP QA Consulting Introduction Global API Manufacturer The client was an API manufacturer, with a need for some support to cope with a deviation backlog. Apotech consultant: Two QA Consultants, with backgrounds in sterile devices. Types of Audits GMP Tools: Ishikawa, 5M Audit Locations Europe Scope of work Under the QA director supervision, our consultant…
Batch Release as EU Qualified Person
Batch Release as EU Qualified Person Introduction Our client is a vertically integrated company in chemical synthesis and manufacturing of generic Active Pharmaceutical Ingredients and Drug Products. Standards and references cGMP ISO 9001 GDPR Trackwise, World Excel, power point Scope of work Remote batch certification and release of medicinal products Provide regulatory expertise as…