Electrical maintenance ensures the proper functioning of electrical equipment, preventing problems that could lead to power loss or an electrical fire. Electrical inspections and tests ensure that equipment does not break. One can minimize the risk of breakdowns by increasing maintenance of your site’s electrical equipment and preventing workplace hazards.
And the main regulatory standard for ensuring pharmaceutical quality is the Good Manufacturing Practice (CGMP) regulation for human pharmaceuticals.
In this article, we’re going to explain GMP regulations in detail.
Let’s get started
What is GMP Pharmaceuticals?
The International Society for Pharmaceutical Engineering defines GMP pharmaceuticals as having regulations on production that ensure quality manufacturing.
GMP is a set of rules and standards that govern how pharmaceutical products are made in order to ensure quality, consistency, and safety. t helps ensure that patients get the right drug at the right dose while also preserving effectiveness and minimizing side effects. GMP was designed to regulate pharmaceutical production, ensuring patients can have access to safe medical
Importance of Quality in Pharmaceuticals
Companies should perform quality assurance at each stage of the drug process, according to the industry guidelines they were following. Drug companies cannot show patients how well quality assurance was done and it puts much pressure on the patient to trust that the product is safe and effective. A drug company’s duty is to provide a safe product by abiding by requirements like those set by the FD&C Act.
Assurance of Quality
Labels on drug products alone will not ensure that consumers and patients are fully satisfied, as the World Health Organization (WHO) lists “Pharmaceutical Quality Systems” as one of the requirements.
PQS is a quality management system that is used to direct and oversee the processes of a pharmaceutical company in terms of quality. According to the Regulatory Education for Industry (REdI) provided by the US FDA, the real assurance of quality in pharmaceuticals is a complete PQS that includes the following:
- QS elements or framework specified in the International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH Q10 on Pharmaceuticals).
- Standards and regulations were given by Current Good Manufacturing Practices (cGMP).
- FDA Evaluation by Inspection
Pharmaceutical Quality System (PQS) Elements
ICH, a council composed of regulatory authorities and pharmaceutical companies, develops ICH guidelines. The guidelines group together (1) Quality protocols, (2) Protocols of effectiveness, (3) Protocols of safety, and (4) Multidisciplinary aspects to advise on PQS. Q10 guidelines are those that center around PQS, the general element in PQS being quality.
- Process performance and product quality monitoring system–use a performance management system to track process performance.
- Corrective Action and Preventive Action (CAPA) system–The CAPA system is used to evaluate the effectiveness of an action.
- Change management system-A system designed to ensure proper scientific and risk-based assessments are provided.
- Management review of process performance and product quality- process performance provides insight into the quality of a product.
GMP in Pharmaceutical Industry
While GMP and cGMP are mostly used interchangeably, the addition of the term “current” to cGMP intends to remind manufacturers that the system and technology they use must be up-to-date, aligned to current standards, or compliant with the latest regulations enforced by FDA.
Manufacturers can follow cGMP regulations to ensure the safety of the drugs they produce, like avoiding contamination and mix-ups. These regulations set the minimum standards for procedures, facilities, and controls used in the process of making, processing, and packaging drugs.
FDA Evaluation by Inspection
The FDA (Federal Food and Drug Administration) is responsible for regulating products and facilities to make sure they comply with safety and efficacy standards. The FDA does this through inspection, evaluating products, and facilities.
- FDA’s Compliance Programs–This document provides guidelines to Federal Drug Administration employees to evaluate the industry’s compliance with the Federal Food, Drug and Cosmetic Act.
- Quality System (QS) Regulations-Quality assurance is a system consisting of the quality system, the control unit, and all of the validation and review responsibilities.
- 21 CFR 211 (cGMP for Finished Pharmaceuticals)-this governs drug manufacturing and manages quality products.
Axonator for Quality Pharmaceutical Products
Quality affects every aspect of the activities of humans. It is an important factor in ensuring the safety and efficacy of drugs and other products for human use. The goal of GMP is to protect the health of patients by ensuring that every medicine they receive meets the highest standards of quality and safety.
Complement your goal of quality with Axonator, the best tool trusted by industries and manufacturers in helping ensure the quality of their products.
Axonator is a digital app that provides a more convenient and efficient approach to conducting compliance checks, quality checks, and inspections. Comply with GMP pharmaceutical standards through the following features:
- Monitor manufacturing processes and practices within your facility to ensure that every process is in compliance with GMP regulations for safety, efficacy, and other quality standards by using the Manufacturing Quality Control Checklist.
- Perform compliance inspections using the General GMP Compliance Checklist and the GMP Pharmaceutical Audit Checklist.
- Address concerns and assign corrective actions to quality problems, deviations, or non-compliance to GMP regulations.
- Maintain the highest quality and integrity, from manufacturing to packaging, and until the distribution of drug products with the Quality Check Sheet Template.
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- Streamline processes and implement a fully automated system within weeks using Axonator’s MicroApp strategy.