Pharmacy Operational Compliance and Internal Audit
Opening a pharmacy is just the first step; the main challenge lies in adhering to strict regulatory requirements in daily operations. The pharmaceutical market in Georgia is under constant state monitoring. Regulatory bodies check medication storage conditions, psychotropic drug logs, sanitary norms, and prescription drug dispensing rules. Violations lead to heavy financial fines, license suspension, or even cancellation. Pharmacy compliance implies a proactive approach: preventing violations before a state inspector discovers them.
Legal.ge offers comprehensive pharmacy compliance services for existing pharmacies and pharmacy chains. Our lawyers and experts conduct internal audits, train staff, and implement Standard Operating Procedures (SOPs), ensuring your business is secure and fully harmonized with legislation.
What Does Pharmacy Compliance Service Cover?
This service focuses on the operational soundness of the pharmacy:
- Mock Inspection: Simulating a regulator inspection to identify and correct deficiencies (e.g., checking temperature logs).
- GDP/GPP Implementation: Implementing Good Distribution Practice and Good Pharmacy Practice standards in daily activities.
- Controlled Substance Monitoring: Auditing documentation for the recording, storage, and dispensing of substances under special control (for Group I pharmacies).
- Staff Training and Qualification: Monitoring compliance with pharmacist certification and continuing education requirements.
- Sanitary-Hygienic Norms: Ensuring pharmacy premises, ventilation, and cleaning regimes comply with technical regulations.
- Waste Management: Legal assurance of procedures for writing off and disposing of expired or damaged medications.
Common Violations and Risks
The most common violation is unauthorized dispensing of prescription drugs. Selling Group II medications without a prescription results in substantial fines. A lawyer helps the pharmacy create internal control mechanisms so staff strictly follow the rules.
Another issue is temperature control breaches. If an inspection reveals fridge temperatures are out of range, the regulator may recall the entire batch. Compliance services include training on maintaining logs correctly and crisis management planning.
Georgian Legislation and Legal Framework
Pharmacy operations are regulated by the Law on Medicines and Pharmaceutical Activities and Government technical regulations on requirements for pharmaceutical institutions. Psychotropic drugs are covered by the Law on Narcotic Drugs, Psychotropic Substances, Precursors and Narcological Assistance. Labor safety and waste management codes are also relevant.
Process of Receiving Services
Cooperation begins with a full audit of the pharmacy. A Legal.ge specialist checks infrastructure and documentation on-site. Based on identified gaps, a recommendation report is drafted. The next stage involves updating documentation (orders, instructions) and briefing staff. As a result, the pharmacy is always ready for state inspection. In case of fines, our lawyers ensure the appeal of the act.
Don't wait for a fine — ensure compliance today with Legal.ge.
Why Choose a Specialist on Legal.ge?
Pharmaceutical regulations change frequently. It can be hard for a pharmacy manager to keep up. Legal.ge experts specialize in healthcare law and possess the latest information on penalty practices and legislative amendments.
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