Good Practice (GxP) Standards are issued by the Authorities, to ensure that specific activities with high impact on people/public health are adequately controlled. These standards are required to be followed by all entities involved in such activities, and during an Authorities inspection, or in case of a client’s audit, these Standards are always within the specifications against which the audit/inspection is performed.

Important GxP Standards are: Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), Good Vigilance Practices (GVP) & Good Clinical Practices (GCP).

The common elements in all GxP Standards are:

  • Quality Management System: The need for an established Quality Management System
  • Personnel Qualification & Training: The need for adequately trained & qualified personnel
  • Record Management: The need for appropriate records to prove compliance with requirements
  • Internal Audits: The need for conduct of periodic Internal Audits
  • Supplier Management: The need to have control over outsourced activities
  • Risk Management: The need to conduct risk Assessments, and act based on risk

 

EU GMP is the framework that ensures medicines are consistently manufactured and controlled according to appropriate quality standards. It covers the entire manufacturing and quality-control system, from starting materials through production, testing, release, and distribution.

The main components of this standard are:

  1. Pharmaceutical Quality System (PQS)
    • Quality manuals and procedures (SOPs)
    • Quality management principles and responsibilities
    • Quality risk management
    • Management review and continuous improvement
    • Deviation, CAPA, and change control systems
  2. Personnel
    • Adequate numbers of qualified staff
    • Defined responsibilities and organisational structure
    • Training and hygiene requirements
  3. Premises and Equipment
    • Suitable facility design and maintenance
    • Prevention of contamination and cross-contamination
    • Qualification, calibration, cleaning, and maintenance of equipment
  4. Documentation
    • Manufacturing and packaging instructions
    • Specifications and testing methods
    • Batch records
    • Data integrity and controlled documentation practices
  5. Production
    • Controlled manufacturing processes
    • Prevention of mix-ups and contamination
    • In-process controls
    • Process validation and ongoing process verification
  6. Quality Control (QC)
    • Sampling and testing of materials and products
    • Laboratory controls and validated analytical methods
    • Stability testing
    • Handling of out-of-specification (OOS) results
  7. Outsourced Activities
    • Requirements for outsourced manufacturing, testing, and other GMP activities
    • Defined responsibilities between the contract giver and contract acceptor
  8. Complaints, Quality Defects and Product Recalls
    • Investigation of product quality complaints
    • Management of suspected quality defects
    • Effective product recall systems
  9. Self-Inspection / Internal Audits
    • Regular assessment of GMP compliance
    • Identification and correction of deficiencies
  10. Qualification and Validation
    • Facility, equipment, utilities, cleaning, processes, analytical methods, and computerized systems
    • Demonstration that systems consistently perform as intended
  11. Materials Management
    • Receipt, sampling, testing, approval, storage, and handling of starting and packaging materials
    • Supplier qualification and monitoring
  12. Computerised Systems
    • Controls over electronic systems used in GMP activities
    • Data integrity, security, access control, validation, and audit trails
  13. Sterile Manufacturing
    • Specific requirements for sterile medicinal products
    • Cleanrooms, environmental monitoring, contamination-control strategy, aseptic processing, and sterilisation

 

EU GDP is the European Union guide for the proper distribution of medicinal products for human use. Its purpose is to ensure that medicines remain safe, effective, and traceable throughout the supply chain, from the manufacturer to the wholesaler, pharmacy, or healthcare professional. GDP focuses on storage, transportation, and distribution.

The main components of this standard are:

  1. Quality Management System (QMS)
    • Quality policy and objectives
    • Standard Operating Procedures (SOPs)
    • Risk management
    • Deviations, CAPA, and change control
    • Continuous improvement
  2. Personnel
    • Competent, adequately trained staff
    • Defined roles and responsibilities
    • Responsible Person (RP) oversight
    • GDP and hygiene training
  3. Premises and Equipment
    • Appropriate storage facilities
    • Temperature and environmental control
    • Security against theft and tampering
    • Qualified and maintained equipment
  4. Documentation
    • Distribution records
    • Temperature logs
    • Training records
    • Data integrity and document control
  5. Operations
    • Receipt and inspection of medicines
    • Stock rotation (FEFO)
    • Storage and handling
    • Order picking and dispatch
    • Verification to prevent falsified medicines entering the supply chain
  6. Complaints, Returns, Suspected Falsified Products & Recalls
    • Investigation of complaints
    • Assessment of returned products
    • Quarantine and reporting of suspected falsified medicines
    • Effective recall procedures and traceability
  7. Outsourced Activities
    • Control of contracted warehouses and transport providers
    • Written quality agreements
    • Supplier and contractor qualification
  8. Self-Inspection
    • Internal GDP audits
    • Monitoring compliance
    • Corrective and preventive actions
  9. Transportation
    • Qualified transport methods
    • Temperature-controlled shipping where required
    • Route risk assessment
    • Monitoring and documentation during transit

 

EU GVP is the European Union framework for pharmacovigilance, designed to ensure that the safety of medicines is continuously monitored throughout their lifecycle. Its main purpose is to detect, assess, understand, prevent, and communicate adverse effects and other medicine-related safety risks, while ensuring that appropriate actions are taken to protect individual patients and public health.

The main components of this standard are:

  1. Pharmacovigilance Quality System
    • Quality objectives and quality management
    • Defined roles and responsibilities
    • Training and competency
    • Quality assurance and quality control
    • Audits and inspections
    • CAPA and continuous improvement
  2. Pharmacovigilance System
    • Establishment and maintenance of a pharmacovigilance system
    • Pharmacovigilance System Master File (PSMF)
    • Oversight of pharmacovigilance activities
    • Qualified Person Responsible for Pharmacovigilance (QPPV)
    • Appropriate resources and organisational structure
  3. Collection and Management of Safety Information
    • Collection of suspected adverse reactions
    • Medical literature monitoring
    • Reports from healthcare professionals or patients
    • Information from clinical trials and other sources
    • Management of safety information from different countries and sources
  4. Individual Case Safety Reports (ICSRs)
    • Receipt and processing of adverse-event reports
    • Validation and duplicate detection
    • Data entry and case assessment
    • Medical review
    • Follow-up of incomplete cases
    • Expedited reporting of qualifying cases to regulatory authorities
  5. Signal Management
    • Detection of potential new safety signals
    • Signal validation and confirmation
    • Signal analysis and prioritisation
    • Assessment of whether further investigation is required
    • Regulatory action and follow-up
  6. Periodic Safety Reporting
    • Preparation and submission of Periodic Safety Update Reports
    • Evaluation of cumulative safety information
    • Assessment of new safety signals
    • Evaluation of the benefit-risk balance
    • Identification of actions needed to manage risks
  7. Risk Management
    • Preparation and maintenance of Risk Management Plans (RMPs)
    • Identification of important identified and potential risks
    • Identification of missing information
    • Risk-minimisation measures
    • Evaluation of the effectiveness of those measures
  8. Benefit-Risk Evaluation
    • Continuous assessment of the medicine's benefits and risks
    • Identification of changes in the safety profile
    • Evaluation of whether the benefit-risk balance remains favourable
    • Regulatory measures when necessary
  9. Post-Authorisation Safety Studies (PASS)
    • Planning and conduct of studies after a medicine is authorised
    • Generation of additional safety information
    • Evaluation of specific safety concerns
    • Assessment of the effectiveness of Risk-minimisation measures
  10. Safety Communication
    • Communication of important safety information to healthcare professionals, patients, and authorities
    • Safety-related regulatory communications
    • Product information updates
    • Appropriate communication of emerging risks
  11. Data Management and Computerised Systems
    • Management of pharmacovigilance database
    • Data quality and integrity
    • Computerised systems supporting PV activities
    • Data security and access control
    • Record retention and traceability
  12. Literature Monitoring
    • Systematic monitoring of scientific and medical literature
    • Identification of suspected adverse reactions
    • Processing and reporting of relevant cases
    • Detection of new safety information
  13. Inspections and Audits
    • Pharmacovigilance inspections by regulatory authorities
    • Internal and external audits
    • Assessment of compliance with the pharmacovigilance system
    • CAPA following identified deficiencies

EU GCP is the ethical, scientific, and quality framework governing the design, conduct, recording, oversight, and reporting of clinical trials involving human participants. Its main purpose is to ensure that the rights, safety, and well-being of trial participants are protected, while clinical-trial data are reliable, credible, and traceable.

The main components of this standard are:

  1. Ethical Principles and Participant Protection
    • Protection of participants' rights, safety, and well-being
    • Respect for autonomy and informed decision-making
    • Ethical conduct of clinical research
    • Balance between potential benefits and risks
  2. Informed Consent
    • Providing participants with appropriate and concise information
    • Obtaining voluntary informed consent before trial participation
    • Documentation of the consent process
    • Special requirements for vulnerable participants and minors
    • Appropriate procedures when participants cannot provide consent themselves
  3. Responsibilities and Roles
    • Clearly defined Sponsor responsibilities
    • Responsibilities of the investigator and trial site
    • Qualified and appropriately trained trial personnel
    • Delegation of trial-related activities
    • Oversight of external service providers
  4. Clinical Trial Protocol
    • Scientific rationale and objectives
    • Trial design and methodology
    • Participant eligibility criteria
    • Treatment and dosing procedures
    • Safety assessment
    • Statistical considerations
    • Data collection and management
    • Procedures for deviations and amendments
  5. Ethics Committee / Regulatory Oversight
    • Independent ethical review of clinical trials
    • Assessment of participant protection
    • Review of informed-consent materials
    • Review of the protocol and relevant trial documents
    • Continuing oversight where required
  6. Risk Management
    • Identification and assessment of risks to participants and trial integrity
    • Proportionate approaches to risk control
    • Risk-based quality management
    • Identification of critical-to-quality factors
    • Preventive and corrective actions
  7. Investigational Medicinal Products (IMPs)
    • Proper manufacturing and handling of investigational products
    • Labelling and packaging
    • Storage and temperature control
    • Accountability and traceability
    • Dispensing and administration
    • Return or destruction of unused IMPs
  8. Safety Reporting
    • Collection and assessment of adverse events and adverse reactions
    • Serious Adverse Events (SAEs)
    • Suspected Unexpected Serious Adverse Reactions (SUSARs)
    • Expedited safety reporting where required
    • Ongoing review of participant safety
    • Identification and management of emerging safety concerns
  9. Clinical Trial Data
    • Accurate and complete data collection
    • Data integrity and traceability
    • Source data and source documents
    • Electronic data systems
    • Data corrections and audit trails
    • Protection against unauthorised alteration or loss of data
  10. Monitoring
    • Oversight of trial conduct and data quality
    • Risk-based monitoring approach
    • On-site and/or remote monitoring
    • Verification that the trial follows the protocol
    • Identification and management of non-compliance
  11. Quality Management
    • Quality management throughout the clinical trial lifecycle
    • Quality risk management
    • Prevention of important errors
    • CAPA
    • Quality oversight of critical trial processes
  12. Computerised Systems
    • Validation and appropriate use of electronic systems
    • System security and access controls
    • Audit trails
    • Data integrity
    • Backup and recovery
    • Management of electronic records
  13. Essential Documents (Documentation & Records)
    • Trial Master File (TMF)
    • Investigator Site File (ISF)
    • Protocol and amendments
    • Informed-consent documentation
    • Regulatory and ethics approvals
    • Training records
    • Monitoring documentation
    • Safety documentation
    • Trial records required to demonstrate compliance
  14. Investigators and Trial Sites
    • Appropriate qualifications and experience
    • Adequate facilities and resources
    • Appropriate delegation of responsibilities
    • Training of trial staff
    • Compliance with the protocol
    • Appropriate medical care for participants
  15. Sponsor Responsibilities
    • Overall oversight of the clinical trial
    • Trial planning and management
    • Selection and oversight of investigators and service providers
    • Safety management
    • Monitoring and quality management
    • Data management
    • Trial reporting and record retention
  16. Audits and Inspections
    • Sponsor audits
    • Regulatory authority inspections
    • Inspection readiness
    • Documentation of findings
    • Corrective and preventive actions
    • Demonstration of GCP compliance
  17. Trial Registration and Transparency
    • Registration of applicable clinical trials
    • Publication of required trial information
    • Reporting of trial results
    • Transparency regarding clinical-trial activities
  18. Trial Completion and Reporting
    • Proper close-out of clinical trial activities
    • Finalisation and reconciliation of trial data
    • Clinical Trial Report
    • Reporting results
    • Archiving of essential documents and records