Quality Standards
The quality of medicinal products is a set of properties due to which they satisfy the needs of customers by their intended purpose. Quality control of medicinal products in Mexican pharmacies includes a set of measures that ensures the preparation of formulations of appropriate quality.
A pharmacy organization bears special responsibility for the goods it sells because is the final point on the way of medicine to the consumer. A pharmacy company needs to create an effective quality management system from the moment drugs are received at the pharmacy until they are sold to the public, ensuring that customers purchase high-quality medical products
Control functions in our pharmacy are entrusted to a pharmacist-analyst, whose competence includes mastery of all types of intra-pharmacy control. His workplace must be equipped with measuring instruments and testing equipment.
To ensure the quality testing of products it is necessary:
- observe the sanitary regime and conditions for aseptic production of medicines;
- comply with the rules for obtaining, collecting, storing purified and injection water, and carry out timely sanitary treatment of the pipeline. Collections for purified water or water for injection must be marked accordingly, as well as a label with the analysis number, date of receipt, and signature of the person conducting the test;
- have serviceable and accurate instruments, regularly check their serviceability;
- carefully check prescriptions received at the pharmacy for the correctness of their prescription (the substances included in the drugs must be compatible; the indicated doses must contain instructions for the use of the drug and correspond to the age of the patient);
- comply with the technologies of all medicines, by regulatory documents, guidelines, and requirements of the State Pharmacopoeia;
- properly store medicines by their physical and chemical properties;
- the rods must contain the analysis number of the control and analytical laboratory, the manufacturer’s batch number, the date of filling, and the signature of the responsible person;
- rods with liquid semi-finished products, tinctures, and solutions must have pipettes or normal drop meters;
- filling of the burette or rod is carried out after processing the rod and complete use of the drug, etc.
We also carry out control during the dispensing of medicines. The control form is aimed at checking all medications manufactured in a pharmacy organization at the time of their dispensing. The pharmacy employee must assess the compliance of the packaging with the physical and chemical characteristics of the substances included in the medicinal product; and correspondence to the age of the patient with the dosage of potent, narcotic, or toxic substances specified in the prescription. In addition, the numbers and surname on the prescription and label, and the patient’s surname on the receipt are compared. Copies of prescriptions must correspond to their prescriptions. The employee who dispensed the drug signs the back of the prescription. At the time of dispensing, it is necessary to evaluate the design of the drug manufactured for the medical institution for the presence of appropriate warning labels.
All specialists working in Mexican pharmacy companies undergo mandatory GMP training at leading Mexican institutions specializing in training pharmaceutical specialists in good manufacturing practices and quality control of pharmaceutical products based on the best global practices. It is highly qualified and competent personnel that is the main factor ensuring the further success of our company.