EU-GMP
Good Manufacturing Practice requirements governing medicinal product manufacture.
Quality & compliance
Systems, records and responsibilities
A factual overview of the activities used to organise quality and regulatory work.
Quality management system
Controlled activity
The system covers governance, procedures, records, training, partner qualification, deviations, change control and review cycles.
EU-GDP
Good Distribution Practice requirements governing wholesale distribution.
GACP
Good Agricultural and Collection Practice for starting materials of herbal origin.
Ph. Eur. 3028
The European Pharmacopoeia monograph setting relevant specifications.
HMR 2012
The Human Medicines Regulations governing medicinal products in the UK.
MDR 2001
The Misuse of Drugs Regulations 2001, as amended in 2018, governing controlled drugs.
UK GDPR
The data protection framework governing the processing of personal information.
Document control
Controlled documents carry an owner, version, approval status and review date. Changes are recorded. Superseded versions are retained within the document history. Scheduled reviews keep responsibilities and current requirements visible.
Pharmacovigilance
Suspected adverse drug reactions should be reported through the MHRA Yellow Card scheme. Reports may also be directed to the relevant prescriber or dispensing pharmacy.
MHRA Yellow CardCompliance enquiries: compliance@bestbotanicals.co.uk