GPP in the pharmaceutical industry on material and technical facilities in Vietnam

GPP in the pharmaceutical industry on material and technical facilities in Vietnam (Internet image)

Regarding this issue, LawNet would like to answer as follows:

1. What is GPP in the pharmaceutical industry?

Good Pharmacy Practice (GPP) means a set of principles and standards for practice at drug retailers (or pharmacies) with the aims of ensuring and improve the direct supply and retailing of safe and effective drugs to patients.

Pharmacist means a person who takes charge of expertise in pharmacy, works at a pharmacy and has obtained formal qualifications in pharmacy in conformity with the type and scope of operation of that pharmacy.

(According to Clauses 1 and 5, Article 2 of Circular 02/2018/TT-BYT)

2. GPP in the pharmaceutical industry on material and technical facilities in Vietnam

GPP in the pharmaceutical industry on material and technical facilities in Vietnam specified in Section II, Appendix I - 1a attached to Circular 02/2018/TT-BYT are as follows:

(1) Construction and design:

- The drugstore must have a fixed place of business, and be built at a safe, high and dry place, far away from sources of pollution;

- Pharmaceutical services and products of the drugstore must be served from an area which is separate from the other activities/services and products;

- The drugstore must be firmly built, have an anti-dust ceiling, easy-to-clean walls and floor, and be well lighted to serve the drugstore's activities and avoid confusion; drugs must be protected from direct sunlight.

(2) Area:

- The area of drugstore premises must be suitable for its scope of business provided that it shall not be smaller than 10m²; the drugstore must have sufficient space for display and storage of drugs, and space for buyers to directly contact and exchange information concerning the use of drugs with pharmacists;

- The drugstore must have separate areas for other activities, including:

= An area for making extemporaneous preparations of prescribed drugs, if any;

= An area for retailing drugs without primary packages;

= A separate area for storage of drugs (if necessary);

= A room or an area for personal consultation for buyers/patients.

- Cosmetics, functional foods and medical equipment (if any) must be displayed in a separate area and not affect drugs; they must be identified by a notice “This product is not a medicine”.

- If a drugstore has the room for making extemporaneous preparations of prescribed drugs or retailing drugs without primary packages:

= This room must have anti-dust ceiling, floor and walls made of easy-to-clean materials; it must be easy to be decontaminated, where necessary;

= It must have a hand washing area, and an area for washing and storing preparation devices and packages;

= Waiting chairs for buyers are not placed in this room.

= All chemicals and instruments for preparation works must be available; there are suitable devices for sterilizing preparation instruments such as dry-heat sterilizers and steam autoclaves; tables for preparing drugs must be easy to clean.

(3) Storage equipment:

- The drugstore must have appropriate equipment for storing drugs and protecting them from adverse effects of sunlight, temperature, moisture, pollution and the infiltration of insects. To be specific:

= Cabinets and shelves must be sturdy, easy to clean, convenient for display and preservation of drugs and beautiful look;

= Lighting must be sufficient for performing activities, checking information on drug labels and preventing or avoiding confusion.

= Thermometers and hygrometers must be available to control temperature and humidity in the retailing area. They must be calibrated periodically as regulated by law.

= The drugstore that applies for issuance of a new Certificate of eligibility for pharmacy business or re-inspection of fulfillment of GPP requirements after the date of entry into force of this Circular is required to equip a temperature data logger with a predetermined periodicity (temperature is commonly recorded for every 30 or 60 minutes depending on each season).

Drugstores that have unexpired Certificates of eligibility for pharmacy business or GPP Certificates must equip temperature data loggers by January 01, 2019.

- Drug storage equipment must be suitable for storage conditions written on the labels. The ambient temperature and humidity must be maintained not exceeding 30°C and 75% respectively.

= Refrigerator(s) or refrigerated storage facilities must be available for drugs requiring storage at cool temperature ((8-15°C) or cold temperature (2-8° C).

- Equipment and packages for dividing and retailing drugs must be suitable for storage conditions written on the labels. To be specific:

= Drugs which are retailed without primary packages must be closely and firmly packaged by appropriate materials to protect drugs;

= Packages or materials packaging retailed drugs must not contain advertising information for other drugs;

= Topical drugs and controlled drugs must be packaged by appropriate materials and easily recognizable;

= Drugs prepared according to prescriptions must be kept in specialized pharmaceutical packages so as to maintain drug quality and differentiate them from other products such as beverages, foods or household goods.

- Drug labeling:

= If drugs to be retailed do not have intermediate packages, name of drug, dosage form, and concentrations or contents of active ingredients must be specified; if drugs are not accompanied by prescriptions, dose and directions must be also specified;

= If drugs are prepared according to prescriptions, in addition to the information mentioned above, date of preparation, expiry date, patient's name, name and address of preparation facility, and cautions for children (if any) must be specified.

(4) Documentation system, records and operational documents:

- Documents or means for searching up-to-date documents concerning directions for use of drugs, applicable regulations on pharmacy and relevant notices by competent pharmacy agencies must be available for pharmacists’ use.

- Records or computers must be equipped to monitor the warehousing, distribution, inventory, batch number, expiry date and origin of drugs and other relevant information, including:

= Drug-related information: Name of drug, number of Certificate of free sale or import license, batch number, expiry date, manufacturer, importer and storage conditions.

= Drug origin: Distributor, date of purchase and quantity;

= Transport facility and storage conditions during the transport of drugs;

= Quantity of drugs of each type purchased, sold and stocked;

= Buyers/patients, retailing date and quantity of drugs sold (with regard to narcotic drugs, precursors, psychotropic drugs, and combined drugs that contain narcotic active ingredients, psychotropic active ingredients or precursors);

= Reference number of prescriptions, prescribers and health facilities if prescription drugs are sold.

- By January 01, 2019, all drugstores are required to have appropriate IT equipment and apply information technology and networking so as to ensure their management of drug origin, prices, and sources of drugs purchased and sold.

The drugstore must set up a mechanism for transmitting information concerning drug purchase and sale as well as drug quality from suppliers to buyers, and transmitting such information to competent authorities as requested.

- All records or documents must be kept for at least one year from the expiry date of drugs.

Records or documents containing information of patients having prescriptions or special cases (patients suffering from chronic disease or requiring follow-up care, etc.) must be kept at a place convenient for use, where necessary;

- Drugstores that trade in controlled drugs must comply with regulations in Article 43 of the Decree No. 54/2017/ND-CP dated May 08, 2017 and relevant documents.

- Documented standard operating procedures must be maintained for every professional operation and followed by all drugstore staff, and include the following primary contents:

= Procedures for purchase of drugs and quality control;

= Procedures for retailing of drugs, provision of information and instructions on use of prescription drugs;

= Procedures for retailing of drugs, provision of information and instructions on use of OTC drugs;

= Procedures for drug storage and control of drug quality;

= Complaints or drug recall procedures;

= Procedures for preparation of drugs according to prescriptions, if any;

= Relevant procedures.

(5) Drugstores that make preparations of narcotic drugs or radiopharmaceuticals must meet material and technical facilities requirements as prescribed in (1), (2), (3) and (4) and specific regulations by the Minister of Health on preparation of narcotic drugs and radiopharmaceuticals in health facilities.

Thanh Rin

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