Good Manufacturing Practices (GMPs) are a collection of various guidelines/guidance documents/directives issued and elaborated by international organizations and institutions. In collaboration with GMP for Pharma industry and several national regulatory authorities in various regions and countries, to ensure the highest standards of efficacy, quality, and safety in any process involving the manufacture of health products.
Pharmaceutical Quality Assurance System
This guideline describes a comprehensive model for an efficacy quality system of medicinal products. They are based on ISO quality concepts and their implementation throughout all stages of the product's life cycle. This policy will promote technological innovation and strengthen the link between Pharma GMP development and manufacturing.
The guideline applies to the development and manufacture of GMP for Pharma industry, substances, active pharmaceutical ingredients, and medicinal products, including biotechnology and biological products, throughout the product's life cycle.
Staff
An enterprise's management should determine and provide adequate and appropriate resources, such as human resources, financial resources, materials, facilities, and equipment. All this is to implement and maintain the Quality Management System and improve effectiveness. Human resource coordination and management are critical factors in the proper operation of any business. To that end, enterprise management is responsible for staff recruitment as well as task delegation.
Property and equipment
Premises and equipment must meet and comply with all rules by the operations to be performed to reduce the risk of errors and allow for effective cleaning and maintenance.
Documentation
The goals of the documentation system must be to establish, monitor, and record all activities that have an impact on all aspects of the quality of medicinal products.
Production
Competent people should perform and supervise production. All material and product handlings, such as receipt and quarantine, sampling, storage, labeling, dispensing, processing, packaging, and distribution, should be done by written procedures or instructions and, if necessary, documented.
Quality assurance
Quality control is concerned with sampling, specifications, and testing, as well as the organization, and documentation. Release procedures ensure that the required and relevant tests are performed and that Pharma GMP products are not released for use, nor are they released for sale or supply until their quality has been judged satisfactory.
Contract manufacturing and analysis/ outsourced activities.
The publication of guidelines on the Activities Subcontracting is based on the Pharmaceutical Quality System to provide updated guidance on GMP-regulated subcontracting activities that extend beyond the current scope of contract manufacture and analysis.
Self-inspection
The goals of self-inspections are to evaluate and supervise the manufacturer's compliance with GMP in all aspects of production and quality control. It must be designed to detect any shortcomings in GMP implementation and to recommend corrective actions.
End
Medicinal Products for Human Use, are based on new techniques and methods that have proven to be more useful for the entire manufacturing process and provide a higher level of quality, safety, and efficacy. There is a growing involvement of organizations and institutions, both public and private, regulatory authorities, and the pharmaceutical industry in achieving maximum harmonization guidelines of GMP for Pharma industry to be used in each country.
No comments:
Post a Comment