Understanding the Basics of QS in Pharmacy
Pharmacy is an important sector that involves the dispensing and administration of drugs and medications to patients. Several factors must be considered by pharmacists when storing, preparing or dispensing drugs, and one of these factors is quality control. Quality control ensures that drugs are safe for consumption and that they meet the necessary standards of quality. One of the most common ways of ensuring quality within the pharmacy industry is by using the QS standard. In this post, we’ll take an in-depth look at what QS is in pharmacy and how it works.
What is QS in Pharmacy?
Quality Standard (QS) in pharmacy, also known as the “Qualitätssicherung” in German, is a set of guidelines that pharmaceutical companies and pharmacies in the European Union use for quality assurance. These guidelines ensure that all activities related to the storage and preparation of drugs are carried out in a safe and effective manner, in line with the regulations governing the pharmacy industry.
The Importance of QS in Pharmacy
QS is an important part of maintaining the high standards of the pharmacy industry. It ensures that all drugs dispensed are safe to use, that the proper storage and transportation methods are in place, and that customer satisfaction is guaranteed. The QS standard is also important in regulatory compliance for government agencies such as the European Medicines Agency (EMA). This agency contains rules and regulations that govern the entire pharmaceutical sector and ensure public safety.
The Elements of QS in Pharmacy
To ensure the highest level of quality control in the pharmacy industry, QS has some elements that must be adhered to:
- Document Control: This element involves maintaining accurate and up-to-date records, including standard operating procedures and batch records, that comply with regulatory guidelines.
- Training and Records: Only those people with the necessary training and experience should be allowed to dispense medication.
- Internal Auditing: This element involves carrying out periodic reviews of the pharmacy’s systems and procedures to ensure compliance with QS standards.
- Corrective and Preventive Action (CAPA): This element ensures that any errors or issues identified through internal audits are addressed and that measures are put in place to prevent their reoccurrence.
- Risk Management: This element involves assessing the potential risks associated with any given activity and taking measures to manage or mitigate them.
How QS in Pharmacy Works
The QS approach in the pharmacy industry is usually carried out in several stages:
- The first stage is usually the assessment of the current quality control procedures and the identification of areas that need improvement.
- Based on this assessment, a plan is developed to address these identified areas of improvement.
- The next stage involves the implementation of the new quality control procedures, training of staff, and ensuring their compliance with the new procedures.
- Periodic reviews and audits are then carried out to ensure continued compliance with QS standards.
- If any issues or areas of non-compliance are identified, corrective action is taken to address them.
The Benefits of QS in Pharmacy
The following are some of the benefits of using QS for quality control in the pharmacy industry:
- It ensures that all drugs dispensed are safe for use and meet regulatory standards for quality.
- It helps to reduce errors in the dispensing of medication and ensure customer satisfaction.
- It ensures regulatory compliance, which means that the pharmacy can operate without fear of penalties or fines from regulatory bodies.
- It boosts the reputation of the pharmacy industry as a whole, ensuring customer trust.
QS is an essential part of maintaining the high standards of the pharmacy industry in Europe. It ensures that all drugs dispensed are safe for use and that the pharmacy operates in compliance with regulatory bodies. Although it may seem daunting, the process of maintaining QS standards is usually simple and straightforward, and most pharmacies have successfully implemented QS standards to improve their operations and provide better customer service.
Here is a list of frequently asked questions and their answers related to QS in pharmacy:
- Question: What are the benefits of using QS in pharmacy?
- Answer: QS helps to ensure that all drugs dispensed are safe for use, regulatory compliance is met, customer satisfaction is guaranteed, and the reputation of the pharmacy industry is boosted.
- Question: What are the elements of QS in pharmacy?
- Answer: The elements of QS include document control, training and records, internal auditing, corrective and preventive action, and risk management.
- Question: How does QS work in the pharmacy industry?
- Answer: QS involves the assessment and identification of areas of improvement, the development of a plan to address these areas, the implementation of new quality control procedures, periodic reviews, and audits of the new procedures to ensure continued compliance, and the taking of corrective action where necessary.
- European Medicines Agency. (2021). Guideline on good pharmacy practice: Inspection of pharmacies. Retrieved from https://www.ema.europa.eu/en/documents/guideline/guideline-good-pharmacy-practice-inspection-pharmacies-revision-2_en.pdf.
- The Pharmaceutical Journal. (2017). Quality management standards in European hospital pharmacies: A general overview. Retrieved from https://pharmaceutical-journal.com/article/research/quality-management-standards-in-european-hospital-pharmacies-a-general-overview.
- USP. (2015). General Chapter <1163> Quality assurance in pharmaceutical compounding. Retrieved from https://hmc.usp.org/sites/default/files/documents/HMC/GCs-Pdfs/c1163.pdf.