GOOD MANUFACTURING PRACTICES
GOOD MANUFACTURING PRACTICES
GMP is an abbreviation for Good Manufacturing Practices. GMP is an initiative of the WHO. The main aim of GMP is to see to it that the products are good enough for utilization after the final outcome. GMP governs the product at each and every step of manufacturing. Good manufacturing practices, along with good agricultural practices , good laboratory practices and good clinical practices , are overseen by regulatory agencies in the United Kingdom, United States, Canada, Europe, China, and other countries. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups, and errors. This in turn, protects the consumer from purchasing a product, which is not effective or even dangerous.
What is GMP
Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products , dietary supplements, and medical devices . These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality management system (QMS).
GMP controls methodologies of manufacture, testing, design and control. The Manufacturers must employ technologies and systems, which are up-to-date. Systems and equipment used to prevent contamination, mix-ups, and errors are adequate by today’s standards.
We offer GMP Compliance Certification to Good Manufacturing Practices- GMP in Pharmaceutical, medical equipment, Food Industries and other relevant industries.
Making poor quality products does not save money. In the long run, it is more expensive finding mistakes after they have been made than preventing them in the first place. GMP is designed to ensure that mistakes do not occur. Implementation of GMP is an investment in good quality medicines. This will improve the health of the individual patient and the community, as well as benefiting the pharmaceutical industry and health professionals. Making and distributing poor quality medicines leads to loss of credibility for everyone: both public and private health care and the manufacturer.
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Good quality must be built in during the manufacturing process; it cannot be tested into the product afterwards. GMP prevents errors that cannot be eliminated through quality control of the finished product. Without GMP it is impossible to be sure that every unit of a medicine is of the same quality as the units of medicine tested in the laboratory.
Most countries will only accept import and sale of medicines that have been manufactured to internationally recognized GMP. Governments seeking to promote their countries' export of pharmaceuticals can do so by making GMP mandatory for all pharmaceutical production and by training their inspectors in GMP requirements.
- Guarantee that the food delivered to the customer fulfills all quality and safety requirements
- Produce a certificate to the customer’s request
- Offer better product quality through better control within its facility
- Guarantee consistent quality conditions within a controlled process on its premises
- Easily meet requirements and inspections from other standards, such as the FDA or HACCP.
GMP regulations address issues including record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls. This provides much flexibility, but also requires that the manufacturer interpret the requirements in a manner, which makes sense for each individual business.
BASIC PRINCIPLES OF GMP APPLICATION
Manufacturing facilities must maintain a clean and hygienic manufacturing area. Manufacturing facilities must maintain controlled environmental conditions in order to prevent cross-contamination from adulterants and allergens that may render the product unsafe for human consumption or use. Manufacturing processes must be clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications. Manufacturing processes must be controlled, and any changes to the process must be evaluated. Changes that affect the quality of the drug are validated as necessary. Instructions and procedures must be written in clear and unambiguous language using good documentation practices. Operators must be trained to carry out and document procedures. Records must be made, manually or electronically, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the food or drug was as expected. Deviations must be investigated and documented. Records of manufacture (including distribution) that enable the complete history of a batch to be traced must be retained in a comprehensible and accessible form. Any distribution of products must minimize any risk to their quality. A system must be in place for recalling any batch from sale or supply. Complaints about marketed products must be examined, the causes of quality defects must be investigated, and appropriate measures must be taken with respect to the defective products and to prevent recurrence.
Frequently Asked Questions
Poor quality food and medicines are not only a health hazard, but a waste of money for both governments and individual consumers.
Good Manufacturing Practices (GMPs) provide a framework of controls that are intended to:
- Protect the product from adulteration or contamination.
- Prevent mix-ups and errors.
- Let you and other personnel know what to do before you or they do it.
- Ensure consistency and control throughout the manufacturing process.
- Ensure quality is designed into the manufacturing process and products.
- Document what really occurred throughout the production cycle.
- Provide an independent group to make the final decisions regarding approval and release or rejection.
- Provide mechanisms for companies to solve problems, learn from mistakes, monitor operations, and continually improve.
- Provide products that meet their established quality specifications.
Yes. Good quality must be built in during the manufacturing process; it cannot be tested into the product afterwards. GMP prevents errors that cannot be eliminated through quality control of the finished product. Without GMP it is impossible to be sure that every unit of a medicine is of the same quality as the units of medicine tested in the laboratory.
Yes. Making poor quality products does not save money. In the long run, it is more expensive finding mistakes after they have been made than preventing them in the first place. GMP is designed to ensure that mistakes do not occur. Implementation of GMP is an investment in good quality medicines. This will improve the health of the individual patient and the community, as well as benefiting the pharmaceutical industry and health professionals. Making and distributing poor quality medicines leads to loss of credibility for everyone: both public and private health care and the manufacturer.
WHO GMP guidelines are available online. If you require more information, please contact the WHO representative in your country, your WHO regional office or WHO headquarters in Geneva.
SOPs define how a company will meet GMP requirements. SOPs are your company's internal regulations; their role is to describe departments' roles, responsibilities and activities. SOPs are written documents that describe in detail, step-by-step, how a procedure, task, operation or function should be done. SOPs are intended to standardize the performance of the procedure to ensure consistent outcome or results each time. Once established, SOPs should be followed as written as they are intended to describe the company-approved method for performing the procedure, task, operation or function. Changes to SOPs should be made under a change control program that includes a review of the impact of the change(s) and approval by appropriate management and the Quality Unit.
An extremely important part of GMPs is documenting every aspect of manufacturing processes, activities, and operations. You could say that SOPs are the foundation of the GMP framework. The purpose of SOPs is to ensure uniformity in the performance of GMP-related operations to assure safe, quality products that meet their established specifications and minimize the potential of adulteration, contamination and/or mix-ups during manufacturing and distribution. SOPs are usually the first item reviewed in a regulatory inspection, and the Natural Products Association third-party auditors will focus the majority of their audit time on reviewing your SOPs for our GMP certification program. Your SOPs and other GMP-documentation such as records are used by FDA and third-party auditors to see how your company operates and to evaluate your GMP compliance.
Additionally SOPs make good business sense because they tell your employees what they are supposed to do, when and how. They can minimize or eliminate contamination, mix-ups and errors which saves time and other resources, improves efficiency, and results in consistent products that meet their established specifications.
A well-written SOP answers the Who, What, Where, When, Why and How questions. Use a standard format or template to ensure that each of these questions is addressed consistently and adequately within company SOPs. Consider developing an SOP on SOPs and good documentation practices.
Every FDA-regulated company should have these 10 standard operating procedures in place:
- Visitor & FDA Inspection policies and procedures
- SOP on SOPs
- Change control
- Quality unit authorities and responsibilities
- Internal audits
- Personnel health, disease control, qualifications and GMP training
- Product review, approval, release or rejection
- Vendor selection and qualification
- Sample storage and retention
- Customer complaints and product recall procedures
This list is not all-inclusive and the actual number of SOPs a company may develop and establish to address the above issues will be dependent upon company philosophies and complexity of operations. This list is reflective of those SOPs that will define the company's management philosophy and policies related to these issues, and also addresses how certain functions or activities will be performed to ensure essential tasks are performed correctly, consistently and in conformance with internally approved procedures. The list does not include operational SOPs, which are dependent upon the actual functions and operations conducted by individual companies within specific facilities.
Additionally, for the purposes of NPA GMP certification, where NPA's GMP standards state that there shall be written procedures—it must be taken as a mandatory requirement to establish one or more SOPs that address that particular GMP requirement.
A controlled document is one that is required by GMP standards or regulations or that otherwise falls under the scope of GMPs. Controlled documents include company program or policy documents that address GMP-related issues or requirements, GMP-related SOPs and records, etc.
When a manufacturer makes permanent changes or modifications to procedures or documentation to address regulatory changes or improvements or modifications in or with their own procedures or facilities, the changes should be reviewed, justified, documented, approved and implemented in a defined, systematic way. This system of documenting and approving permanent changes has become known in GMP parlance as "change control." Temporary changes are considered deviations and should be addressed in conformity with appropriate documented procedures. Change control with its components of review, justification, documentation, approval and implementation allows us to evaluate the potential impact of change on regulatory guidance, previously approved procedures and documentation as well as on product quality and in some cases safety. Change control procedures must be formalized and identify what is and what isn't covered by the procedure and how proposed changes will be identified or recommended, processed, reviewed and approved. While the cGMPs assign approval responsibility to the Quality Unit, other specialty groups may also be assigned or required to review procedures, e.g., engineers, chemists, computer experts, etc.
Yes, the final FDA GMPs requires you to verify that every finished batch of dietary supplement meets each product specification for identity, purity, strength, composition and for limits on contamination that may adulterate your product. Specifically, under 21 CFR 111.75(c) and (d), you must select and test or examine one or more established finished product specifications (for identity, purity, strength, composition, and limits on contaminants that may adulterate your product) to verify that your manufacturing process has yielded a finished batch that meets all product specification except those exempted by quality control personnel under §111.75(d). You also must provide adequate documentation for why meeting these specifications will ensure your finished batch meets all product specifications and quality control personnel must review and approve such documentation.
The rule provides some flexibility in this area, requiring testing of every finished batch or alternatively, allowing for testing a subset of batches identified using a sound statistical sampling plan. The rule also allows you to exempt one or more product specifications from the verification (testing or examination) requirements if you determine and document that the specification cannot verified through testing because there is no scientifically valid method for testing the exempted product specification at the finished product stage and the specification can be verified through component and in-process testing or examination. Additionally, the rule allows you to select one, two, three or more specifications that could be used to demonstrate compliance with specifications if testing these specifications will verify that the other untested specifications are met. Once again, you must document your basis for why this is so and your quality control personnel must review and approve such documentation.