Pharmaceutical Quality Assurance Services for GMP and GDP Compliance
Practical quality assurance support for pharmaceutical manufacturers, importers, wholesalers and distributors.
Myloy Health provides pharmaceutical quality assurance services to support companies involved in the manufacture, importation, storage and distribution of medicinal products.
Our quality assurance support is focused on maintaining effective Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) systems, helping organisations maintain appropriate quality controls throughout the pharmaceutical supply chain.
We provide support with Qualified Person (QP) services, Responsible Person (RP) services, GMP and GDP audits, batch release, quality management systems, supplier qualification, deviations, CAPA, quality risk management, product quality reviews and other pharmaceutical quality activities.
Our services can be tailored to the specific requirements of pharmaceutical manufacturers, marketing authorisation holders, importers, wholesale distributors and other organisations operating within the regulated pharmaceutical supply chain.
Qualified Person (QP) Services
The Qualified Person has a critical role in ensuring that medicinal products manufactured or imported into the European Union comply with applicable requirements before being certified for release to the market.
Myloy Health can provide Qualified Person (QP) support for relevant pharmaceutical operations, including activities associated with manufacturing and importation.
Our QP-related quality assurance services include:
Batch Certification and Batch Release
Support with the pharmaceutical batch certification and release process, including review of relevant manufacturing and quality control documentation.
Activities may include review of:
- Batch manufacturing records
- Batch packaging records
- Certificates of Analysis
- Quality control results
- Deviations and investigations
- Out-of-Specification (OOS) investigations
- Change controls
- CAPA
- Stability information
- Relevant manufacturing and testing documentation
- Supplier and material information, where applicable
The precise scope of review is determined according to the applicable procedures, responsibilities and regulatory requirements.
GMP Audits and Inspections
GMP audit and inspection support for pharmaceutical manufacturers, suppliers and other relevant organisations.
Our GMP audit activities can include assessment of areas such as:
- Pharmaceutical quality systems
- Manufacturing operations
- Documentation and data integrity
- Quality control laboratories
- Deviation and investigation management
- CAPA systems
- Change control
- Supplier qualification
- Training
- Validation and qualification
- Production and process controls
- Storage conditions
- Complaints and recalls
- Quality risk management
We can also support organisations in preparing for regulatory or customer inspections by reviewing their quality systems and identifying potential areas requiring attention.
GMP Manufacturing and Importation Support
Quality assurance support relating to the manufacture and importation of medicinal products.
This can include review and oversight of relevant GMP activities, documentation and quality systems to support compliance with applicable requirements.
Quality Management System (QMS) Support
A robust pharmaceutical Quality Management System (QMS) is fundamental to maintaining GMP compliance.
Myloy Health can support the establishment, maintenance and improvement of pharmaceutical quality systems, including:
- SOP review and development
- Quality procedures
- Deviation management
- CAPA management
- Change control
- Quality risk management
- Supplier qualification
- Training systems
- Documentation management
- Quality metrics and monitoring
- Management review
- Continuous improvement
Learn more about our Quality Management System services.
Process Review and Manufacturing Oversight
Review and oversight of pharmaceutical manufacturing processes to assess whether appropriate controls are in place and whether processes are operating in accordance with applicable procedures and GMP requirements.
CAPA Management
Support with the management and follow-up of Corrective and Preventive Actions (CAPA) arising from deviations, audits, inspections, complaints, investigations and other quality events.
This may include:
- Review of identified root causes
- Assessment of proposed corrective actions
- Assessment of preventive actions
- Effectiveness checks
- CAPA follow-up and closure
Deviation Investigations
Support with the assessment and investigation of deviations from approved procedures, specifications or established requirements.
Deviation investigations should establish the circumstances and potential impact of the event and, where appropriate, identify root causes and corrective and preventive actions.
Quality Risk Assessments
Support with quality risk management and documented quality risk assessments for pharmaceutical operations.
Risk assessments can be used to support decisions relating to manufacturing, quality systems, suppliers, processes, changes and other quality-related activities.
Supplier Qualification
Support with the qualification and ongoing assessment of suppliers relevant to pharmaceutical manufacturing and quality operations.
Supplier qualification activities may include:
- Supplier assessment
- Supplier questionnaires
- Quality documentation review
- GMP compliance assessment
- Supplier audits
- Risk-based supplier evaluation
- Ongoing supplier monitoring
Product Quality Review
Support with Product Quality Review (PQR) activities, including assessment of relevant manufacturing and quality information over the review period.
Depending on the product and scope, this may include review of:
- Batch information
- Deviations
- CAPA
- Changes
- OOS results
- Complaints
- Recalls
- Stability data
- Analytical results
- Qualification and validation information
- Previous PQR findings
Quality Control and Laboratory Data Review
Review and interpretation of relevant pharmaceutical quality control and laboratory information.
This can include assessment of analytical results, laboratory data, specifications and trends, as appropriate to the scope of the assignment.
Statistical and Trend Analysis
Quality data can be assessed using appropriate statistical or trending approaches to identify recurring issues, potential trends and areas requiring further investigation.
Stability Data Review
Review of relevant stability information and results as part of pharmaceutical quality activities and product quality assessments.
Out-of-Specification (OOS) Management
Support with the assessment and management of Out-of-Specification (OOS) results, including review of investigations and proposed corrective and preventive actions.
Responsible Person (RP) Services
Myloy Health also provides Responsible Person (RP) quality assurance support for pharmaceutical wholesale distribution activities.
The Responsible Person has an important role in ensuring that wholesale distribution activities comply with applicable Good Distribution Practice (GDP) requirements and that an effective quality system is maintained.
Our RP-related services include:
RP Batch Release
Support with the review and release of medicinal products within the scope of the applicable wholesale distribution operations and procedures.
Batch release activities may include review of relevant documentation and confirmation that the required quality and distribution controls have been appropriately addressed.
GDP Audits and Inspections
GDP audit and inspection support for wholesale distributors, suppliers and other relevant organisations.
Our GDP assessments can cover areas including:
- Quality Management Systems
- Storage and distribution practices
- Temperature-controlled storage
- Temperature monitoring
- Transportation
- Supplier qualification
- Customer qualification
- Complaints
- Recalls
- Returns
- Deviations
- CAPA
- Quality risk management
- Documentation
- Training
- Self-inspections
- Management review
GDP Quality Management System Support
Support with maintaining and improving a Good Distribution Practice (GDP) Quality Management System.
This may include:
- SOP review
- Quality procedures
- Deviations
- CAPA
- Change control
- Quality risk management
- Supplier qualification
- Training
- Complaints
- Recalls
- Returns
- Self-inspections
- Management review
CAPA Management
Support with the management, documentation and follow-up of CAPA arising from deviations, audits, inspections and other quality events.
Supplier Qualification
Support with the qualification and monitoring of suppliers involved in pharmaceutical wholesale distribution.
A risk-based approach can be applied to supplier assessment, including review of relevant quality and compliance information and, where appropriate, supplier audits.
Deviation Investigations
Support with the investigation and assessment of deviations from established procedures or GDP requirements.
Quality Risk Assessments
Support with documented quality risk assessments relating to pharmaceutical storage, distribution and quality systems.
Temperature Mapping
Support with temperature mapping of storage areas to assess temperature distribution within relevant storage environments.
Temperature mapping is an important element in demonstrating that storage areas can maintain the required environmental conditions for the products being stored.
Temperature Monitoring System Validation
Support with the assessment and validation of temperature monitoring systems used for pharmaceutical storage and distribution activities, within the agreed scope of the assignment.
Product Quality Complaints
Support with the management and assessment of pharmaceutical product quality complaints.
This may include:
- Complaint assessment
- Investigation support
- Documentation review
- Communication with relevant parties
- CAPA identification
- Follow-up and closure
Pharmaceutical Product Recalls
Support with pharmaceutical recall activities and the associated quality system processes.
Recall procedures should allow affected products to be identified and appropriate actions to be taken in accordance with applicable procedures and regulatory requirements.
Quality Management Review
Support with Quality Management Review activities to assess the performance and effectiveness of the pharmaceutical quality system.
This can include review of relevant quality indicators, deviations, CAPA, complaints, audits, supplier performance and other quality information within the defined scope.
GMP and GDP Quality Assurance Support
Myloy Health can support pharmaceutical organisations across a range of quality assurance activities, including:
GMP Quality Assurance
- Qualified Person (QP) support
- Batch certification and release
- GMP audits
- GMP inspection preparation
- Manufacturing oversight
- Importation quality activities
- Product Quality Reviews
- Quality Management Systems
- Deviations
- CAPA
- Change control
- Quality risk management
- Supplier qualification
- OOS investigations
- Stability data review
- Laboratory data review
GDP Quality Assurance
- Responsible Person (RP) support
- GDP audits
- GDP inspection preparation
- Wholesale distribution quality systems
- Batch release activities
- Temperature mapping
- Temperature monitoring systems
- Supplier qualification
- Deviations
- CAPA
- Quality risk assessments
- Complaints
- Recalls
- Returns
- Quality Management Review
Who Can Benefit From Our Quality Assurance Services?
Our pharmaceutical quality assurance services can support organisations including:
- Pharmaceutical manufacturers
- Pharmaceutical importers
- Wholesale distributors
- Marketing authorisation holders
- Pharmaceutical companies establishing or maintaining GMP systems
- Companies establishing or maintaining GDP systems
- Organisations preparing for GMP or GDP inspections
- Companies requiring additional quality assurance resources
- Organisations requiring specialist support for specific quality projects
The exact scope of services is agreed according to the organisation’s activities, responsibilities, products and applicable regulatory requirements.
Why Choose Myloy Health for Pharmaceutical Quality Assurance?
Effective pharmaceutical quality assurance requires more than simply having documented procedures. Quality systems need to be implemented, monitored, reviewed and continuously maintained.
Myloy Health provides practical regulatory and quality assurance support designed around the specific requirements of each client and assignment.
Our services combine pharmaceutical regulatory knowledge with practical quality management support across GMP, GDP and pharmaceutical quality systems.
We can provide support for individual quality projects as well as ongoing quality assurance requirements, depending on the client’s needs and the agreed scope of work.
Pharmaceutical Quality Assurance Services in Malta
Myloy Health is a pharmaceutical consultancy based in Malta, providing regulatory, pharmacovigilance and quality-related services to organisations operating in the life sciences sector.
For companies operating in Malta, we can provide local support for relevant GMP, GDP and pharmaceutical quality assurance activities, subject to the scope and requirements of the individual assignment.
Our quality assurance services can be particularly relevant to organisations requiring support with pharmaceutical manufacturing, importation, wholesale distribution and associated quality systems.
Quality Assurance, QP and RP Services – Frequently Asked Questions
What is a Qualified Person (QP)?
A Qualified Person (QP) is a suitably qualified individual with defined responsibilities under EU pharmaceutical legislation relating to the manufacture and certification of medicinal products.
The QP’s responsibilities include ensuring that the relevant requirements have been fulfilled before a medicinal product is certified for release, within the scope of the QP’s legal and professional responsibilities.
What is a Responsible Person (RP)?
The Responsible Person is responsible for ensuring that a wholesale distributor operates in accordance with applicable Good Distribution Practice requirements and maintains an effective quality system appropriate to its activities.
What is GMP?
Good Manufacturing Practice (GMP) comprises the requirements and principles intended to ensure that medicinal products are consistently produced and controlled according to appropriate quality standards.
GMP applies to relevant manufacturing activities and is a fundamental component of pharmaceutical quality assurance.
What is GDP?
Good Distribution Practice (GDP) provides requirements for the wholesale distribution of medicinal products and is intended to help ensure that the quality of medicinal products is maintained throughout the distribution supply chain.
What is a Pharmaceutical Quality Management System?
A Pharmaceutical Quality Management System is the structured system of processes, procedures, responsibilities and controls used by an organisation to manage and maintain pharmaceutical quality.
An effective QMS supports activities such as deviations, CAPA, change control, quality risk management, supplier qualification, complaints, audits and management review.
Can Myloy Health provide GMP and GDP audits?
Yes. Myloy Health provides GMP and GDP audit and inspection support, with the precise scope agreed according to the organisation, site, activities and objectives of the assignment.
Can Myloy Health support pharmaceutical companies with QP activities?
Myloy Health can provide QP-related quality assurance support, including activities such as GMP audits, batch release-related activities, quality system support, manufacturing oversight and review of relevant quality information, subject to the specific scope and responsibilities agreed for the assignment.
Can Myloy Health provide RP services?
Myloy Health provides Responsible Person-related GDP quality assurance services, including GDP audit support, quality system activities, supplier qualification, deviation and CAPA management, temperature-related quality activities, complaints, recalls and quality management review, subject to the specific scope of the assignment.
Can quality assurance support be provided on an ongoing basis?
Yes. Quality assurance support can be structured around specific projects or ongoing requirements, depending on the organisation’s needs and the services required.
Request Pharmaceutical Quality Assurance Support
If your organisation requires QP services, RP services, GMP support, GDP support, pharmaceutical quality assurance, batch release, quality management system support or audit assistance, contact Myloy Health to discuss your requirements.
We can assess the scope of your activities and identify the quality assurance support appropriate for your organisation.
Contact us to discuss your GMP, GDP and pharmaceutical quality assurance requirements.
