What is MHRA Full form?
Medical and Healthcare Products regulatory agency is UK regulatory authority for medicine and medical device.
Which country does MHRA regulate?
MHRA Regulate medicine and medical device in UK i.e. wales, northern irland ,england scotland.
What is the frequency of MHRA Audit?
Frequency of MMHRA Audit is 2 to 3 years dependinng on risk assessment and compliance history.
Q. What are 5 area in which MHRA commonly look during the audit of pharmaceutical industry?
1. Quality Management Systems: Assessing the effectiveness and compliance of the quality management systems in place.
2. Good Manufacturing Practice (GMP) Compliance: Ensuring adherence to GMP standards throughout the manufacturing process.
3. Documentation and Record Keeping: Reviewing the accuracy and completeness of documentation and records.
4. Staff Training and Competency: Evaluating the training programs and competency of the staff involved in pharmaceutical production.
5. Product Quality and Safety: Inspecting measures to ensure the quality and safety of pharmaceutical products.
Q. What is role of MHRA in pharmaceutical industry?
1. Surveillance and Authorization:
• Operate post-marketing surveillance and the Yellow Card Schem
• Authorize medicinal products for sale in the UK.
• Oversee Notified Bodies for medical device compliance.
2. Quality Assurance and Enforcement:
Conduct quality surveillance of medicines.
Investigate and prosecute internet sales and counterfeiting. 3. Safety Promotion and Data Management:
Promote safe use of medicines and devices.
• Manage Clinical Practice Research Datalink & BP
Q. Compliance with which regulatory guidelines is important for clearing MHRA Audit in pharmaceutical company ?
1. Good Manufacturing Practice (GMP) – EU GMP Guide Part I (Annex 1-20), Part II (Annex 21-25), and Part III (Annex 26-29).
2. Good Clinical Practice (GCP) – ICH E6 (R2) and GCP Directive
2005/28/EC
3. Good Distribution Practice (GDP) – GDP guidelines as per EU Directive 2013/C 343/01 and EU Guideline 2013/C 343/01. 4. Pharmacovigilance (PV) – EU PV Guidelines as per Directive 2001/83/EC, Volume 9A and Volume 9B.
5. Data Integrity – Data Integrity and GMP as per EU GMP Guide Annex 11
Q. What are the typical timelines for responding to MHRA audit findings ?
Typically, companies are expected to respond to MHRA audit findings within 15 to 30 days, depending on the severity and complexity of the findings.
Q. What is the MHRA Yellow Card Scheme?
It’s a scheme for reporting suspected side effects or incidents involving medicines, vaccines, and medical devices.
Q. What types of products does MHRA regulate?
MHRA regulates pharmaceuticals, biological medicines, medical devices, blood and transplant materials.
Q. How does MHRA enforce compliance ?
MHRA enforces compliance through inspections, issuing licenses, and taking regulatory actions against non-compliant manufacturers.
Q. In which cases MHRA performs unannounced audit?
1. Serious Complaints or Whistleblowing: Investigating credible reports of serious non-compliance.
2. Product Recalls or Defects: Addressing major defects or significant product recalls.
3. Previous Non-Compliance: Checking on companies with a history of unresolved non-compliance.
4. Safety Concerns: Investigating safety issues or adverse effects reports.
5. High-Risk Products or Processes: Ensuring stringent standards for high-risk products or complex processes.
Q. Which documentation required for MHRA audit ?
Essential documentation includes quality management systems, batch records, validation reports, and SOPs (Standard Operating Procedures).
Q. What are measures does MHRA take to ensure confidentiality and security of audit findings ?
MHRA maintains confidentiality of audit findings and ensures secure handling of sensitive information obtained during inspections.
Q. What steps can a pharmaceutical company take to prepare for an MHRA audit?
Companies should conduct internal audits, maintain comprehensive documentation, train staff on regulatory requirements, and address any identified deficiencies.
Q. What is major differe between MHRA audit and USFDA Audit?
| Aspect USFDA Audit MHRA |
1) Regulatory Authority FDA (United States) (United Kingdom and EU) |
| 2) Standards cGMP GMP, GDP, GCP, PV |
| 3) Geographical Scope United States United Kingdom and EU |
| 4) Audit Process Includes pre-announced inspections rarely unannouced inspection Includes announced & unannounced inspections |
| 5) Enforcement Actions Issues Warning Letters, Import Alerts Improvement Notices, non- compliance notices |
