In-Pharmacy Quality Control of Medicines and Its Characteristic Features

In-pharmacy quality control of medicines is an integral part of the pharmaceutical quality assurance system. It guarantees that medicinal products manufactured in pharmacy conditions or received from manufacturers comply with established requirements for safety, purity, and efficacy.

Types and Methods of In-Pharmacy Control

Acceptance control includes a comprehensive check of incoming medications according to the parameters of integrity of the secondary and primary packaging, correctness of labeling, presence of certificates of conformity, and quality passports. Organoleptic analysis evaluates appearance, color, specific odor, homogeneity, and the absence of visible mechanical impurities. Physical control checks the total mass or volume of the extemporaneous form, deviations in the mass of individual doses, and the quality of closure.

Chemical analysis is divided into qualitative acceptance control to confirm the authenticity of ingredients and full quantitative analysis of active substances. Questioning control is applied selectively immediately after drug preparation to verify compliance with the sequence of technological operations from the specialist's memory. Control upon dispensing is the final stage, verifying the correspondence of the packaging, signature, and dosage to the original prescription or medical institution request.

Interrelation of In-Pharmacy Control and GMP Principles

GMP standards regulate the industrial sector, however, the basic principles of the quality system are naturally integrated into pharmacy manufacturing:

•     Compliance with sanitary and hygienic regime, surface disinfection, and control of microbiological air purity in the aseptic unit.

•     Validation and metrological verification of measuring instruments, analytical balances, refractometers, and sterilizers.

•     Strict logging of processes, maintaining journals of manufactured forms, and preserving analytical records.

•     Use of certified chemical reagents, titrated solutions, and pharmacopeial standard samples.

•     Systematic certification of pharmacist-analysts and continuous staff training on operating rules.

The implementation of GMP principles combined with multi-stage in-pharmacy control prevents substandard or falsified drugs from reaching patients. Documentary transparency, automation of accounting operations, and standardization of procedures ensure a stable level of quality for manufactured forms. Systemic auditing of processes within the pharmacy guarantees the preservation of the declared pharmacological properties of medications throughout their entire shelf life.