GMP Certification: Consultants in India
GMP stands for Good Manufacturing Practice regulations developed by the (FDA) Food and Drug Administration under the authority of the FDA- Federal Food, Drug, and Cosmetic Act (See Chapter IV for food, and Chapter V, Subchapters A, B, C, D, and E for drugs and devices.)
These regulations and requirements, which are as per law, require that manufacturers, processors, and packagers of drugs, IVD devices, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, regulated and effective.
GMP standard requirements and regulations require a basic quality and risk approach to manufacturing (the entire chain), enabling companies to improve quality, reduce or eradicate occurrences of non-conformities and/or contamination, mix-ups, and errors. This actually protects the end-user / consumer from purchasing a product that is not effective or maybe it is not safe, there is lesser quality assurance of the product, or, even that the product is dangerous. Failure of companies to conform with the requirements of GMP standard regulations might result in serious consequences including failures, recalls seizure, fines, and jail.
GMP standard regulations address issues (internal/external) including documentation, procedures, SOPs, record keeping, personnel qualifications & awareness, sanitation, cleanliness, equipment verification, process validation, and complaint handling; packaging and labeling, etc. Most GMP standard guidelines and CFR requirements are very general, as normally standards are, accepting manufacturers themselves to decide respectively how effectively to interpret and implement the necessary controls. This means that it provides more tractability, but also generically requires that the manufacturer company effectively interpret the guidelines and requirements in an approach that will make sense for each individual business.
GMP sometimes is referred also being as “cGMP”. The “c” stands for “current,” asking manufacturers that they must employ current and advanced technologies and systems that are up-to-date in order to comply with the regulation. Systems, Infrastructure, and Equipment being used to proactive prevent issues, problems, contamination, mix-ups, and non-contaminations and errors, which may have been very good some years ago, but during current/modern times, may be less than adequate by current standards.
What is the meaning of good manufacturing practice (GMP)?
Good manufacturing practice (GMP) is basically a conceptual standard that guarantees products are consistently (quality and all technical specification wise) and continually being manufactured and the various processes are controlled according to proven quality standards requirements. The standard requirements have been designed/developed in a way to proactively control the risks to the end-user from items and products out of production from the company- Food & drugs, Cosmetics, Medical Devices, Pharmaceuticals, etc.
GMP constitutes an assurance to operate in some sectors’ manufacturing and sometimes is a core condition worldwide. However, rules and interpretations differ from one country to another and many times, change frequently. Therefore, having fully trained consultants like Ascent WORLD to help with the implementation of these rules is very important.
GMP or, Good Manufacturing Practices, or at times affixed with a “c” as cGMP (meaning Current GMP) is basically a Quality System which includes requirements and guidelines for the manufacture, inspection and testing of Medical Devices, IVD products / Items, Medicines/Drugs/pharmaceuticals, active pharmaceutical ingredients, Diagnostics products/items, and Food items. It generally encompasses the Manufacturing and Logistics associated with the above-mentioned processes.
A Facility / Company / Organization can reap the following benefits, amongst others, from implementing and Certification towards GMP or cGMP:
- Establishes the fact that the Organization is following to Guidelines set by WHO or FDA and including Local Nationalized standards and Guidelines.
- Ensures hygiene and cleanliness requirements throughout the Manufacturing and Logistics Chain.
- Good Documentation Practices- documents (eg. Manual, Procedures, SOPs, operational Controls, Risk Assessment, Regulatory Compliances, etc) and Records for evidence.
- Design and Operation including management of processes and products related to Medical Devices, IVD products / Items, Medicines/Drugs/pharmaceuticals, active pharmaceutical ingredients, Diagnostics products/items, and Food items.
- Establishes the Competence (including Technical) of Personnel.
- Establishes the Organization’s system of handling Non-Conformities and Complaints, including proper reporting to Regulatory bodies, wherever required.
- Reduction of Costs and best possible Utilization of Resources.
- Evidence of Safe and Quality Products and Items.
- Compliance with all International and National and Local Regulations.
- Builds Customer Assurance and Rapport and Trust.
- Entry to International Markets.
- Professional Culture within the organization.
- Reduction of Complaints, Fines, Product Returns, Re-processing, Rejections, Non-Conformities, and Claims.
GMP / cGMP is a set of “Industry Best Practices” to ensure and assure Quality, Safety, Consistency, and Efficacy of the Product / Item being manufactured.
These guidelines follow a few basic principles:
- The manufacturing, logistics, packaging, and labeling including distribution, of the products, must mitigate any risk to their quality and safety.
- Manufacturing facilities (including all relevant areas eg QC, Logistics area, etc) must maintain a certain degree of cleanliness and hygienic facilities area, including laboratories and storage.
- Manufacturing facility design, Equipment and Machinery design, procedures & operating principles and environmental conditions must be controlled in order to prevent cross-contamination of products and further to prevent cross-contamination from labeled or un-labeled material or products.
- Manufacturing practices and processes including health & safety, maintenance, etc must be clearly defined, validated, and controlled to ensure consistency and compliance with specifications. Any changes to any process are evaluated from a consumer safety and product quality perspective, and any approved change that might affect the safety and quality of the product/item should be qualified or validated as necessary.
- Instructions and standard operating procedures and policies and evidence (data collection and reporting) are maintained in a clear and unambiguous legible language (Good Documentation Practices).
- Operators should be aware and trained and made competent to carry out the production, QA/QC, Logistics, Factory Management, and control of products for the full stages of production to dispatch to reaching the end-user- according to well-documented and approved and in a way- validated procedures.
- Records should be maintained for manufacture and quality control, and logistics- thereby demonstrating that all the necessary steps required by the defined procedures and instructions were executed as defined and that the specified quality attributes of the products have been met.
- Deviations are instantly and thoroughly investigated and documented.
- The processes and system should remain in control (including approvals and controls from the Top Management) throughout the product lifecycle and improvements were done as needed.
- Records of manufacture (including distribution) are retained in a comprehensible and accessible format (hard or soft- it doesn’t matter) that can trace the full history (procurement, receipt of raw materials, processing/manufacturing, QQC activities, packaging/labeling, dispatch) of the batch.
- Records should be maintained for 5 to 10 years- based on regulatory requirements.
- A system must be maintained and established for recalling any batch from sale or supply.
- Complaints and appeals (Contact Ascent WORLD for ISO 10002, ISO 10004, ISO 10006, and other similar standards) about marketed & sold products should be verified, the potential and root causes of quality defects investigated, and appropriate measures are being undertaken with respect to the non-conformity and/or defective / error products and to prevent a similar recurrence.
GMP standard guidelines are not mandatory/prescriptive instructions/procedures on how the company/organization shall manufacture products. They are a set of general principles that must be applied during manufacturing, QA/QC, Logistics, and general Factory Management. When a company is implementing its QMS system, manufacturing processes, and various controls (at various stages/processes or sub-process level), there may be different ways to fulfill GMP requirements. It is the company’s responsibility and Management’s accountability to determine the most effective and efficient quality process.
Why is GMP so important in Food & Drugs, Pharma, Cosmetics, Medical Devices, and IVD engineering?
Poor quality products can be a serious disaster for both customers, consumers, and governments from a health and a cost perspective. If manufacturing companies cannot manufacture appropriate safe for consumption and quality products due to GMP reasons (the most common reason as cited) there might be a high risk of shortage, which unfortunately affects end-users and customers who cannot get their required and specified product what they need. The industries have a consolidated responsibility to ensure their safe and sufficient supply, and this must be taken into consideration in products’ engineering and consulting projects from the outset.
Additionally, GMP certification can help boost export opportunities. The majority of companies worldwide, generally accepted as an assurance model, the import and sale and consumption of products that have been manufactured to globally renowned GMP Standards. Investing in implementing and certifying to GMP means participating in the distribution and consumption of quality and safe products. It might save costs of non-conformities, minimizing and control risks, and hence definitely improves the safety and quality of the standard of products/items throughout.
How to Sustain GMP Compliance- How can Ascent WORLD help on this:
GMP compliance requirements and regulations are developed to enhance the safety of manufactured products and to ensure consumers get the highest quality possible. GMP compliance greatly and in a positive manner impacts the reputation of the manufacturing companies, rapport increment with all relevant interested parties, compliance with change management, compliance with regulatory guidelines and, also minimizes non-conformities and batch recalls and adverse reports from consumers and/or end-users.
Below are 5 measures any company can follow to sustain GMP compliance:
- Quality team
Have a team of experienced, qualified, and capable personnel that might concentrate on the improvement and continual growth of current manufacturing methods and complying with GMP. These core personnel will perform quality assessments on operations to identify problems and develop appropriate corrective measures. Part of the team’s responsibility shall include conducting scheduled and available monitoring of facilities, instruments, equipment, processes, and staff skills.
Validation is a definitive requirement and the evidenced act of demonstrating that instruments, processes, and activities are consistent. This is done usually to check if they work and perform the functions in the required conditions and according to expectations. GMP can actually entail a lot of things which might need to be validated, but it’s kind of required to consider the following:
- Personnel validation
- Process validation
- Cleaning and sanitation- hygiene validation
- Computer system validation
- Health & Safety validation
- Environmental and waste management validation
- Analytical method validation
- Internal Audits
An Internal audit (conducted by Ascent WORLD) at frequent intervals can help gain more accurate insight on what goes on in the facility. Identification of potential as well as real root causes of non-compliance and take action before it progresses into a larger issue. Also, finally taking corrective actions and verifying the effectiveness.
- Compliance Training- (conducted by Ascent WORLD) Providing compliance training to staff (conducted by Ascent WORLD) is one of the best ways to ensure GMP compliance. Helping personnel and employees (all relevant) gain a clearer understanding of GMP principles and requirements and hence continually improve operations, processes or systems in place to ensure that relevant systems and processes or Deptt are GMP-compliant. All employees and (relevant process) personnel should receive adequate awareness and training on document maintenance, procedure following, recordkeeping, cleanliness and sanitation, non-conformity, product knowledge, manufacturing, and related processes, proper equipment handling, and packaging/labeling, and SOPs to minimize errors, risk controls and measures and maintain compliance.
Strengthen GMP in your Organization:
Having well-documented processes and comfortable processes and systems that implement and supervise standards can strengthen GMP implementation and compliance in the organization. With technological advances in the industry, all companies/manufacturers should have more opportunity and controls in place to transform a reactive system (doing after a problem) culture, into a proactive (before a problem occurs) one, a predictive and competent and knowledgeable workforce (employees/personnel and all relevant) equipped for continuous improvement, including doing change management wherever relevant and required. Utilize (Ascent WORLD) expertise to move your GMP beyond compliance.