Good Industry Practices:

1)Good Manufacturing Practice-GMP;

2)ISO 22716-2017-Cosmetics- Good Manufacturing Practice (GMP);

3)ISO 15378 -2017- Primary Packaging Materials for Medicinal Products;

4)WHO GMP-Good Manufacturing Practice Herbal Medicines

5) Codex Good Manufacturing Practice for Food Establishments.

Introduction to GMP- Good Manufacturing Practice

Good manufacturing practice (GMP) 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.

The main risks are: unexpected contamination of products, causing damage to health or even death; incorrect labels on containers, which could mean that patients receive the wrong medicine; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects.

2.What is GMP -Good Manufacturing Practice

GMP –Good Manufacturing Practice-is part of a quality system covering the manufacture and testing of active pharmaceutical ingredients (Pharma GMP), pharmaceutical products (Pharma GMP) Foods Products (Codex GMP), Cosmetics (Cosmetic GMP) and Herbal Products (Herbal GMP).

Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation.

GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be observed during manufacturing.

Ten Principles of Good Manufacturing Practice

1. Design and construct the facilities and equipments properly

2. Follow written procedures and Instructions

3. Document work

4. Validate work

5. Monitor facilities and equipment

6. Write step by step operating procedures and work on instructions

7. Design ,develop and demonstrate job competence

8. Protect against contamination

9. Control components and product related processes

10. Conduct planned and periodic audits

3. Why GMP -Good Manufacturing Practice:

• Ensuring the safety and efficacy of drug products and medical devices.
• Is a legal regulations, based on the United States Food, Drug and Cosmetic Act.

4.Who should apply

Companies / Person(s) who import or manufacture pharma/cosmetic products, or have products imported or manufactured on their behalf are responsible for applying to the authority to have their products registered

Our GMP Consultants with Pharma, Bulk Drug and Food Industry background will help in application of GMP Principles.

5. What are the benefits GMP brings to business:

1. Increases the creditability and offers a competitive advantage in the marketplace for contract manufacturers
2. Increases senior management confidence in the preparedness of manufacturing facilities for inspection;
3. Decreases the time and cost for companies selecting contract manufacturer.

1.Introduction to ISO 22716-2007-Cosmetics – Good Manufacturing Practice (GMP)

Consumers are becoming more and more concerned about the safety of the cosmetic products they are using. Fears of allergies and dermatitis caused by tainted or poisoned cosmetics have been ever-present in recent years. Certain ingredients used in cosmetics, such as fragrances and preservatives, can trigger an allergic reaction. Obviously, these ingredients play a pivotal role in the cosmetic products of our choice and correct dosing of these substances therefore is of key importance to avoid irritation of the skin through over-exposure. Examples of over-exposure to preservatives have frequently been observed in several historic cases, one example being beauty creams that contained mercury. Beauty creams occasionally were reported to contain excess amounts of mercury, with poisoned consumers exhibiting clear toxic neurological symptoms.

2. What is Cosmetic GMP- Good Manufacturing Practice:

Cosmetic GMP-ISO 22716 is an international standard for the cosmetics manufacturing industry.It describes the basic principles of applying GMP in a facility that produces finished cosmetic products and offers organised and practical advice on the management of human, technical and administrative factors affecting product quality.

ISO 22716 covers manufacturing, storing, packaging, testing and transportation processes. It does not apply to research and development activities and the distribution of finished cosmetic products. Even though the standard focuses on product quality, it does not include the safety of the employees engaged in production or protection of the environment.

3. Why Cosmetic GMP-

• Improves quality manufacturing management efficiency including continual improvement
• guarantees quality and safe use for the consumer
• positively influences key customer retention
• maintains overall competitiveness

4. What benefits Cosmetic GMP- Good Manufacturing Practice it brings to Business?

• Enables the organisation to manage the quality and safety requirements of its supply chain.
• Controls hazards and risks associated with cosmetic products, ensuring continuous improvement.
• Implemented easily in all sizes and levels of complexity, and compliance of legal requirements.
• Ensures that the organisation meets legal compliances.

5. Whom Cosmetic GMP- Good Manufacturing Practice is applicable:

• Cosmetic product manufacturers, distributors and importers / exporters.
• Not applicable to research and development activities and distribution of finished products.

1.Introduction to ISO 15378:2017 -Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)

The ISO 15378:2017 – Primary Packaging Materials for Medicinal products was developed by stakeholders in the pharmaceutical sector to provide a Quality management system for suppliers of materials intended to be used as packaging for medicinal products.

This International Standard identifies Good Manufacturing Practice (GMP) principles and specifies requirements for a Quality management system applicable to primary packaging materials for medicinal products. The realization of GMP principles in production and control of primary packaging materials within organizations is of great importance for the safety of a patient using the medicinal product, because of their direct product contact. The application of GMP for pharmaceutical packaging materials helps ensure that these materials meet the needs and requirements of the pharmaceutical industry.

2. What is ISO 15378:2017

ISO 15378:2011 specifies requirements for a quality management system for manufacturers of pharmaceutical and medical device primary packaging materials. These organisations need to demonstrate their ability to consistently meet customer requirements, including regulatory requirements and international standards applicable to primary packaging materials for such medicinal products.

3.Why ISO 15378: 2017

• To comply with legal requirements for pharmaceutical and medical device primary packaging materials;
• To reduce the risks of safety hazards and product contamination, and ensure product efficacy and shelf life.

4. What benefits of ISO 15378:2015 brings to business:

• Decrease and control of risks
• Presentation of the company’s expertise
• Creation of competitive advantages
• Time and cost savings
• Evidence of compliance with statutory regulations and contractual agreements
• Development of the quality ability

5. ISO 15378 is applicable to

Pharmaceutical and medical device primary packaging materials include glass, rubber, plastics, aluminium containers/components, films, foils and laminate containers.

1.Introduction to WHO –GMP -Good Manufacturing Practice–Herbal Medicines

With the constant increase in the use of herbal medicines worldwide and the rapid expansion of the global market, the safety and quality of herbal materials and finished herbal products have become a major concern for health authorities, pharmaceutical industries and the public.

2. What is Herbal GMP- Good Manufacturing Practice

Good manufacturing practices (GMP) is one of the most important tools for this measure. The core requirements for GMP for herbal medicines are common to GMP for pharmaceutical products.

3. Why Herbal GMP- Good Manufacturing Practice

The safety and efficacy of herbal medicines largely depend on their quality.

Requirements and methods for quality control of finished herbal products, particularly for combining/mixing

herbal products, are far more complex than for chemical drugs.

The quality of finished herbal products is also influenced by the quality of the raw materials used.

4.What benefits Herbal GMP brings to business:

• Increases the creditability and offers a competitive advantage in the marketplace for contract manufacturers.
• Increases senior management confidence in the preparedness of manufacturing facilities for inspection

5. Whom Herbal GMP is applicable:

Manufacture of herbal medicinal products, raw materials and ingredients manufacturers.

1.Introduction to Codex GMP: Recommended International code of practice- General principles of food hygiene.

People have the right to expect the food they eat to be safe and suitable for consumption. Foodborne illness and foodborne injury are at best unpleasant; at worst, they can be fatal. But there are also other consequences. Outbreaks of foodborne illness can damage trade and tourism, and lead to loss of earnings, unemployment and litigation. Food spoilage is wasteful, costly and can adversely affect trade and consumer confidence.

International food trade, and foreign travel, are increasing, bringing important social and economic benefits. But this also makes the spread of illness around the world easier.

Eating habits too, have undergone major change in many countries over the last two decades and new food production, preparation and distribution techniques have developed to reflect this. Effective hygiene control, therefore, is vital to avoid the adverse human health and economic consequences of foodborne illness, foodborne injury, and food spoilage.

2. What is codex GMP:

These General Principles lay a firm foundation for ensuring food hygiene and should be used in conjunction with each specific code of hygienic practice, where appropriate, and the guidelines on

microbiological criteria. The document follows the food chain from primary production through to final consumption, highlighting the key hygiene controls at each stage. It recommends a HACCP-based approach wherever possible to enhance food safety as described in Hazard Analysis and Critical Control Point (HACCP) System and Guidelines for its Application (Annex).

3. Why Codex GMP-

Food spoilage is wasteful, costly and can adversely affect trade and consumer confidence.

International food trade and foreign travel are increasing, bringing important social and economic benefits. But this also makes the spread of illness around the world easier.

Eating habits too, have undergone major change in many countries over the last two decades and new food production, preparation and distribution techniques have developed to reflect this.

Effective hygiene control, therefore, is vital to avoid the adverse human health and economic consequences of food borne illness, food borne injury, and food spoilage.

4. What are the benefits of Codex GMP-

• Demonstrating your commitment to food safety
• Providing confidence to your customers
• Providing a systematic methodology to effectively identify and manage food safety risks
• Promoting the review and continual improvement of your food safety management system

5. Whom Codex GMP is applicable:

Everyone, including farmers and growers, manufacturers and processors, food handlers and consumers, has a responsibility to assure that food is safe and suitable for consumption.

Governments, industry (including individual primary producers, manufacturers, processors, food service operators and retailers) and consumers alike.

6. Our Consulting approach:

• Gap Analysis: Assessment of existing management system practices against the selected standard requirements.
• Project Plan: Prepare a implementation project plan based on the time lines looking for;
• Orientation Training: Top/Senior Management orientation on selected standard requirements and implementation action plans preparation;
• Developing different levels of documentation ( Tier 1-3/4): Identification of processes required for the products produced and services provided; External and internal issues affecting the business, interested parties needs and expectations, Framing draft quality policy, organizational objectives, role, responsibility and authority, various risks affecting and opportunities arises, functional and system procedures, different implementation formats and checklists;
• System Implementation: Implementation of the selected management system as per the developed documentation;
• Company-wide Training: Training on detailed clause wise requirements and relating them to their departments, 5-S implementation, and Internal audit.
• Internal Audits: Periodic assessment of system implementation and corrective actions.
• Pre assessment: Initial audit by Certifying agency, and, implementation of corrective actions.
• Final Assessment: Certification audit by the Certifying agency and recommendation for certification.