GMP – Production 360º
Good Manufacturing Practices
GMP (Good Manufacturing Practices) are a system to ensure that products are consistently produced and controlled in accordance with the quality standards, covering the following areas: API, Excipients, Finished Dosages, Packaging, Medical Device, Subcontracted Laboratory and Starting Materials.
Different types of GMP audits
API (Active Pharmaceutical Ingredient) in GMP is any substance or mixture of substances intended to be used in the manufacture of a drug product and that, when used in the production of a drug, becomes an active ingredient in the drug product.
A GMP API audit will review API specifications and test methods; stability studies results; Impurity profile.
These audits verify that specifications and test methods are validated, and all procedures were conducted correctly and under GMP guidelines.
Pharmaceutical excipients are essential to the safety, quality, and efficacy of drug products, as they impact a variety of factors influencing how a drug enters and interacts with the body.
An Audit for GMP Excipients covers the following critical activities and includes principles and guidance to Quality Management System – general requirements and documentation requirements; such as change control, management responsibility, resource management, excipient realization; measurement, analysis, and improvement.
GMP for finished dosages are products in a finished dosage form (e.g., tablet, capsule, or solution) that contains at least one active pharmaceutical ingredient, generally, but not necessarily, in association with other ingredients in finished package form suitable for distribution to pharmacies, hospitals, or other sellers.
The audit shall ensure that finished dosages are done to a GMP standard by auditing finished product: verification of materials, components, label verification, storage, and handling, finished product inspection, sampling, testing, and release for distribution.
GMP for packaging ensures that the product must be manufactured under a GMP program that prevents contamination and guarantees safety. Therefore a GMP audit will check for but will not be limited to: packing operations following instructions using specified materials described in a master packaging procedure, if details of the operation are recorded on the batch packaging record, all deliveries of bulk products and packaging components are checked and verified, If packaging containing pre-coding is checked for correctness before and after the transfer of packages, or if pre-coded packaging happens in isolated areas.
Procedures should be in place describing receipt and identification of bulk packaging components, proper control to assure correct printed and unprinted packaging components used, in-process control, and reconciliation of bulk products and printed packaging materials. In regards to the packaging operation, checks shall be carried out to ensure the area and equipment are free from residues, contaminants, etc, therefore, ensuring proper line clearance is conducted.
GMP for medical devices is a system that ensures the device can be consistently produced and controlled by the proper quality standards. This system also helps risk management practices since following the GMP system minimizes risk.
An audit for GMP medical devices shall review design and development protocols, SOPs, etc checking for effectiveness and if procedures align with regulations in ISO 13485 and FDA 21 CFR 820.30.
The audit shall identify and verify if production and product controls, and purchasing controls align with regulations in ISO13485 and FDA 21 CFR 820.80.
The audit shall review documentation and records; along with customer-related processes such as intended use, customer communications, and product orders.
GMP for subcontracted laboratories provides analytical services to the manufacturer. With GMP for subcontracted laboratories, we can assure that the manufacturing process remains safe throughout the entire process, including In process controls and testing.
Audit for subcontracted lab shall be performed as any other GMP/GLP laboratory. Audits can be conducted by a regulatory agency or the contracting lab.
Two types of audits are performed Study Audits and Vendor Audits. Analysis procedures (Study Audit) include but are not limited to: reviewing protocol and compliance to protocol, reviewing SOP and compliance to procedures, performing in-process study inspections, conducting data reviews, conduct reviews of draft and final reports.
Vendor Audits include but are not limited to: performing routine and qualification audits of contract laboratories, inspecting facilities and equipment, reviewing organization structure and SOP content, assessing qualification and training of personnel, assessing testing facilities operation including test and control articles, reviewing records, reports, and record/sample retention, assess data transfer process, assess QA unit.
GMP for starting materials is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
Starting Materials are raw materials, an intermediate, or an API that is used in the production of an API and is incorporated as a significant structural fragment into the structure of the final API.
GMP requirements must be met as soon as a starting material is first used in the active ingredient manufacturing process.
An audit for starting materials should include but is not limited to verifying the qualifications of applicants and assessors on the suitability of the starting material defined in the application, review and verifying requirements (and expectation of the competent authority) to describe the manufacturing process of a starting material in such a way that quality assurance can be conclusively verified throughout the whole process.