GxP – New Standards For Cannabis Products Quality Assurance

GxP – New Standards For Cannabis Products Quality Assurance

GxP stands for ‘Good Practices.’ The “x” can be replaced with Agriculture, Auditing, Documentation, Manufacturing, Clinical, Distribution, Security, Laboratory, Storage, Distribution, Review and others.

Good practices are the recommended working procedures and methodologies employed, in order to comply with health regulation bodies and guidelines and to achieve a safe, effective, accurate, reliable, consistent and pure-drug substance, drug-product or medical device.

The main aspects of GxP are:

  • Quality – The capability to ensure that medical products consistently meet applicable requirements and specifications
  • Integrity – Compliance to a code of moral and ethical standards as well as data and full documentation integrity
  • Traceability – The ability to reconstruct development history, status and location of each individual substance, drug product or medical device batch from the manufacturing process until the retail agent/distribution process.
  • Accountability – The acknowledgment and capability to take full responsibility for actions, processes and decisions related to medicinal products, from raw material through the shelf-life termination period.

Documentation is a critical tool to be used as part of the GxP implementation and compliance process. GxPs are a collection of guidelines intended to produce and supply medicinal products or services in compliance with regulations and common industry practices in regulated industries such as drugs, food, and medical. These industries are obligated to have safe products that constantly meet defined quality criteria which should be implemented in a strict and controlled way, including R&D, manufacturing processes, quality control, storage and distribution. Medicinal products and medical devices pose a great risk to human health, and as such should be subjected to regulatory requirements and responsibility.  It is essential during such a process for quality standards  to be managed, implemented, trained and followed and continuous improvement over time is mandatory. The International Organization for Standardization (ISO), International Standard 13485: 2015 defines the term “quality” as a “set of characteristics that a product or service must have to satisfy the needs and expectations of a customer.”

In August 2002 the FDA announced a new initiative “Pharmaceutical cGMPs for the 21st Century – A Risk-Based Approach” which was also included in the ISO 13485 several years later. The purpose of this initiative was to enhance and modernize regulations and FDA responsibility of pharmaceutical, manufacturing and product safety.

The initiative aims at encouraging the adoption of new technological advances by the pharmaceutical industry, as well as implementation of quality system approaches, implementation of risk-based approaches, in order to minimize the risk patients and end users are exposed to.

Primary areas covered by GXP include:

  • GMP- Good Manufacturing Practice
  • GLP- Good Laboratory Practice
  • GCP- Good Clinical Practice
  • GDP (1)- Good Documentation Practice
  • GDP (2)- Good Distribution Practice
  • GSP- Good Storage Practice
  • GAP- Good Agriculture Practice
  • GEP- Good Engineering Practice
  • GRP- Good Review Practice

GMP – Good Manufacturing Practice

Good Manufacturing Practices (GMPs), also known as Current Good Manufacturing Practices (cGMPs), are manufacturing and administrative procedures and practices aimed to ensure that medicinal products, medical devices, food supplements and cosmetic products meet the required manufacturing standards, specifications and customer expectations in order to supply a safe and effective end-product.

GMP regulations include a variety of products such as human pharmaceuticals and veterinary products, biologically derived products, medical devices, packaging or food products. The principle of regulation is that quality cannot be tested in the final product and/or in a specific batch or test, but rather be being integrated into the entire manufacturing process, from raw material receiving and testing, until final product storage before distribution. GMP principles implementation include receiving and in-process testing, in conjunction with other controls, monitoring and  testing will enable minimal risks during production that cannot be eliminated by testing of the final product only.

In the United States, the Food and Drug Administration (FDA) issued these regulations as the minimum requirement for drug substances, drug products, medical devices, supplements and cosmetic products. Quality Assurance, production managers and senior management are responsible for ensuring that all procedures, practices, policies and SOPs comply with cGMP guidelines.

Ten basic principles of the GMP:

  • Proper design and construction of the facility, utilities and equipment
  • Proper Maintenance of utilities and equipment
  • Validation of facility, utilities, equipment, manufacturing processes, cleaning, testing methods and software
  • Composition of standard operating procedures and follow them
  • Correct Document processes
  • Employees certification, development and training
  • Contamination protection and prevention
  • Employees health/hygiene
  • Quality built into the whole product lifecycle
  • Audits and inspections

GCP – Good Clinical Practice

Good Clinical Practices (GCPs) are international ethical and scientific quality standards for the design, conduct, performance, monitoring, auditing, analysis, reporting and regulation of human clinical investigations. Clinical investigations are experiments and studies in which a medical product such as a drug or device is administered or dispensed to, or used involving, one or more human subjects. Documentation of compliance with GCP standards is required for clinical investigations submissions to the regulatory ‎agencies in USA, Europe, Japan and Canada. These standards provide assurances that the rights and confidentiality of trial subjects are protected and that the data and reported results are credible and accurate (for more information about clinical trials…link).

ICH (Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) the GCP guidance objective is to provide a unified mutual standard for the United States, the European Union (EU) and Japan for clinical data by the regulatory authorities in these jurisdictions.

The guidance was developed considering the current best clinical practices in the United States, European Union, Japan, Australia, Canada, the Nordic countries, and the World Health Organization (WHO).

ICH “efficacy” has many topics relating to this (E1 to E12A). ICH – E6 is relevant to Good Clinical Practice.

 

GLP – Good Laboratory Practice

GLP regulations are international standards relevant to research, development and QC laboratories used for pre-clinical trials and studies, planned and executed. Studies being performed in a certified GLP laboratory should be monitored, recorded, and then archived. GLP regulations were published by the US Food and Drug Administration in 1976. The quality aspects of GLP are defined by its capability to repeatedly provide the same testing and analysis services for the same specifications and levels. GLP includes the capability to protect the data integrity and quality of laboratory data. GLP implementation performed based on written working procedures (SOP’s) and documentation of the work as it is being done. The purpose of GLP is to support the development of quality and validated testing data used to verify the safety and compatibility of product specification. GLP regulation requirements cover several subjects, which include:

  • General requirements- Qualified personnel, adequate resources, Sanitation, employee health verification, garment, data storage
  • Facilities requirements-appropriate size, contamination separation, construction materials, sample storage
  • Equipment requirements- operational accessibility, efficiency, suitable for production rate, routinely maintained & calibrated, validation for equipment, validation for testing methods
  • SOP’s -Testing, sampling, data documentation, sample storage, equipment maintenance & calibration, labeling of samples and materials, protocol indicating test objectives & methods, final report of results, records retention, deviations investigations, out of specifications.

 

 

GSP – Good Storage Practice

Good Storage Practice ‎is part of quality assurance that describes the proper storage conditions that must be kept in order to maintain the quality of pharmaceutical and medicinal products.

As part of the supply chain, which includes manufactured products storage and transportation, multiple risks are involved which include mix-ups, contamination and cross-contamination. The multi stage risks can be managed by the correct assimilation of GMP principles.

The following guidelines must be met for GSP: Storage areas must be suitably secured, structurally sound and with a sufficient capacity to allow for safe storage and handling. Storage areas must be have adequate lighting and climatic conditions and must prevent unauthorized persons from entering restricted storage areas. Defined segregated areas and software management will be performed according to product status. Storage areas should be clean and dry with temperature and humidity control. Pharmaceutical products shall be stored off the floor. Proper documentation of stock quantities and products expiration dates must be clear. Products should be appropriately rotated. In most cases, “first expired/first out” (FEFO) principle should be followed.

Additional regulation guidelines in World Health Organization (QHO) Annex 9

Guide to good storage practices for pharmaceuticals.

GDP – Good Distribution Practices

GDP describes the proper distribution and shipping practices of pharmaceutical and medical products for human us, as well as regulations for materials and product transportation between destinations and sites. The Drugs & Cosmetics Act 1940, set specific conditions to be fulfilled to sell, stock, exhibit or offer for sale or distribute drugs and medicinal products in America.

The quality system should ensure that the right products are delivered to the right destinations within a satisfactory time period under appropriate environmental conditions and controls. Distribution is an essential activity and is an integral part of the supply chain of pharmaceutical and medicinal products. GDP aspects include acquisition, storage, distribution, transportation, documentation and record keeping practices. It is essential to maintain adequate controls during distribution‎ in order to maintain the quality and shelf life of pharmaceutical products. Pharmaceutical and medical product distribution should be carried out according to the principles of Good Distribution Practices. A validated track & trace system should be capable of finding a specific product in case of a recall procedure. In general, GDP risks are similar to GSP risks and can also be managed by assimilation of proper GMP principles. GDP guidelines will ensure the quality of pharmaceutical products during the distribution process. The guidelines are intended for all personnel involved in the distribution of pharmaceutical products, from storage to dispensary or directly to the patient. For additional information see U.S. Pharmacopeia chapter <1079> ‘Good Storage and Distribution Practices for Drug Products and World Health Organization Annex 5 good distribution practices for pharmaceutical products.’

GRP – Good Review Practices

GRP is documented in the Center for Drug Evaluation and Research (CDER) that describes the process, format, content and/or management of a product review. GRP’s were developed as guidances for review staff or as manuals of policies and procedures (MAPPs). An example of GRP is MAPP 6010.3 Rev.1 Good Review Practice:  Clinical Review Template. This is a standard clinical review template describing the format and content of a new drug application review. GRP policies are updated regularly as advances are made in science, statute updates, regulation changes, and accumulated experience is gathered over time.

GRPs are developed as superior practices based on CDER’s collective experience to provide consistency to the overall review process of new products. GRPs are developed to improve the quality of reviews and review management. GRPs improve efficiency, clarity, and transparency of the review process and review management. GRPs are expected to be adopted by review staff as standard processes through supervisor mentoring, implementation teams, and formal training when necessary.

GRP collaborates policies from various offices within the CDER which include: Review Management, Biometrics, Clinical, Clinical Pharmacology, Non-Prescription‎ Products, Safety, Chemistry, Manufacturing, and Controls, Pharmacology/Toxicology. GRPs fundamental values are quality, efficiency, clarity, transparency and consistency.

 

GAP – Good Agricultural Practice

GAP is essentially the quality and control of agricultural products. It is based on the principals of risk prevention, risk analysis, sustainable agriculture and the means for continuous improvement of farming systems. GAP is essential in protecting consumer’s health and well-being. In order to guarantee the safety for the consumer, the entire food chain must be regulated and therefore validated. GAP is essential for international trade in food to developed countries were GAP is used. Consumers are increasingly concerned about food safety, how it was grown, produced, and how it is handled within the supply chain. GAP is able to provide consumers with the sense of quality that they require.

GAP is not limited to food; it includes herbal medicines as well. The quality of herbal medicines play a major role in its function and lack of quality may result in adverse effects on patients.

The safety and quality of raw herbals and finished products made from herbals depend on the genetics of the growing conditions (environment, nutrients, pesticides, cultivation, harvest, post-harvest processing, and storage.) Proper sanitation, pest and microbiological controls should be implemented during growing and through the supply chain in order to maintain the safety and quality of all herbal products.

GAP includes the following fields:

  • Security for the farm
  • Safety of the food
  • Environment
  • Farming systems, live stock care, proper nourishment

 

About Cannabis GxP consultancy

Cannabis GXP is proud to stand at the forefront of the Cannabis industry in Israel and worldwide thanks to many years of experience in these areas.

Our team is compelled to spread the message of the importance of cannabis science, regulation and standardization as the world enters a new era of cannabis legislation.

We aim to position our clients with their best foot forward when it comes to anything and everything cannabis related.

Our vast expertise allows us to assist companies in a wide range of services and needs: Anything from Cannabis R&D, growing and manufacturing, new products development, facility design, technology, Quality Assurance, Good Practices (GAP/GMP/GLP/GDP/GCP), staff training, local and global regulations.

Cannabis GxP is a subsidiary company of Bio-Chem Ltd. (2007), a consultancy firm for the Pharmaceutical field, Medical devices, Cosmetics and food supplements industry based in Israel.

Our cannabis consultancy services include:

  • Product development, delivery system & clinical trials
  • Growing, Manufacturing and Lab Facilities Design
  • Quality Assurance and Good Practices (GxP)
  • Cultivation & Product Manufacturing Technology
  • New product Regulations and Submissions
  • Qualification & Validation
  • Risk Assessment
  • Staff training

If you need one or several of our services, we will be more than happy to assist.

Please do not hesitate to contact us for further information.

2019-05-19T12:09:32+00:00

contact us