Information

1.20: Good Manufacturing Practices (GMPs) - Biology


Learning Objectives

Goals:

  • Make a batch of Good Manufacturing Practice (GMP) popcorn within a specified timeframe (1.5 hours).
  • Use Standard Operating Procedures (SOPs) to accomplish the manufacturing task.
  • Understand the complexity of the GMP process.
  • Understand Quality Control (QC) and Quality Assurance (QA).
  • Understand the need for team members to complete individual jobs appropriately to accomplish goals.

Student Learning Outcomes:

Upon completion of this lab, students will be able to:

  • Explain the role of Standard Operating Procedures (SOPs) and batch/lot Records.
  • Employ the principles of a quality systems approach to manufacturing.
  • Learn the difference between Quality Control (QC) and Quality Assurance (QA).
  • Discuss the value of teamwork.

Part I: Review Terms and Background Information

Introduction

In everyday speech, quality is a relative attribute like beauty. However, in the Life Sciences or any other manufacturing-related industry quality means compliance to specifications. Quality systems are comprised of the policies, processes, and procedures for maintaining a product with specifications.

This lab exercise will utilize the manufacturing of a popcorn snack as an example where good manufacturing practices (GMPs) can be followed. The exercise used the components of a Quality System. Students are the employees with tasks to accomplish within the defined QA/QC parameters.

Quality Management Systems (QMS)

Quality is the business of the entire company. Generally, companies build their quality systems by first making a commitment by management to design and deliver a ‘quality’ product. The term quality management system refers to the organizational resources, processes, and procedures to implement quality management. In the case of pharmaceuticals, diagnostics and medical devices, these requirements mean the product is EXACTLY what was tested in clinical trials.

Quality product management is usually implemented through two departments; quality assurance (QA) and quality control (QC). The QA department plans activities and develops the processes that guarantee the accuracy and precision of outputs. QC performs the actual tests during the process and on the final product to ensure that specifications are met. Quality Assurance is process oriented and focuses on defect prevention, while quality control is product oriented and focuses on defect identification. QC refers to a measuring process, or to check a result and provide assurance that all activities are performing within predetermined limits.

Often, QMS systems are explained in this simple statement: Say what you do, do what you say, document it.”

Say What You Do = SOPs

Standard Operating Procedures (SOPs) and documentation are essential components of a QA program. The management team is responsible for ensuring adherence to the QA plan and SOPs. Essential to this process is documentation of the proposed quality system and processes used by the company.

Perhaps the most important form of documentation is SOPs. SOPs are validated methods that are at the technical core of the product or service. To determine whether methods are fit for their intended purpose, the selected methods must have established accuracy, precision, calibration and limits of detection and quantification. All methods must be fully validated for accuracy and precision before a company starts to sell its product or service.

Do What You Say = Follow the Process (SOPs)

Quality systems are implemented in many sectors of the life sciences industry including manufacturing, a testing laboratory, clinical trials or even Research and Development. In all cases the SOPs must be followed. In the example of a manufactured product, all manufacturing employees follow the defined process and document that they have done so. The QC department provides the process checks and balances. For example, they manage the acceptance and release of raw materials, in–process checks and testing of the final product.

Document It = Evidence of Quality

If you didn’t write it down = you didn’t do it!

No documentation = no PROOF you did it!

No documentation = BAD product and lost money for your company

Current Good Manufacturing Practices (cGMPs)

The general principles that all QMS have in common are:

  • Say what you do. Quality, safety, and effectiveness must be designed and built into the product, not tested or inspected into the product.
  • Do what you say. Each step in the manufacturing process must be documented and controlled to ensure the finished product meets design and regulatory specifications.
  • Document it. Process documentation provides evidence of compliance with cGMPs.

Statistical Process Control

Another aspect of a quality program it use of statistical process control (SPC), which utilizes statistical methods to evaluate variability in procedures. In the design of the product, multiple data sets are obtained to establish accuracy and precision criteria. These criteria are documented in the Master Record. QC testing procedures ensure SPC through instrument calibration and validation, in process testing, final product testing, raw material testing etc. They use process control charts to monitor the process and procedures in order to manage variability.

The purpose of the quality systems is to ensure quality. Since quality is defined as compliance to specifications, a statistical process control (SPC) must be established to ensure this compliance. The SPC requires understanding of both the accuracy and precision required in the product.

Accuracy is the ’right answer’ or ‘bulls-eye". Accuracy is not always known but when it is, it is part of the process. Precision is reproducibility. Whatever the process or procedure, the quality system is there to ensure reproducibility.

The ideal situation is when precision and accuracy are on target: Expected and observed values are close and the results are consistently reproducible. If results are reproducible but the results are not close enough to the expected value, one has good precision but poor accuracy. Poor precision but good accuracy occurs when the results are not close to each other in value but they all fall within an acceptable target range. This situation often can be improved upon with the appropriate action. Poor precision and poor accuracy is typically the most problematic result since neither reproducibility nor an expected target value have been achieved (Figure 2).

Corrective and Preventative Actions (CAPA)

The purpose of the Corrective and Preventative Actions (CAPA) system is to serve as a feedback loop to identify and investigate all quality problems. CAPA policies are central to a quality system. Part of the QC testing that takes place on every lot of product, is to assure compliance to specifications. If the specifications are not met, it is important to determine what is the root cause of the problem. Until the root cause is used to identify the cause of problems with accuracy and precision, product quality cannot be assured.

Quality Assurance and Quality Control (QA/QC)

Table 1. Quality Assurance Versus Quality Control
ElementQuality Assurance (QA)Quality Control (QC)
Definition

the activities focused on the processes for preventing mistakes and producing products free of defects

a set of activities concerned with monitoring and verifying resulting products meet the defined standards and specifications for quality

PurposeVerification: Answer the question "Am I building the product correctly"?
Prove the system meets all specified requirements at a particular stage.
Validation: Answer the question "Am I building the right product"?
Ensure that the product meets customer expectation.
Type of processProactiveReactive

Goal

Plan to prevent problems

Identify defects in the finished product

Identify and correct source of product defects

Tools

Statistical Process Controls:
Control Charts
Run Charts

Statistical Quality Controls:
Random Acceptance Sampling
Range Charts
Histograms
Means
Standard Deviation

Responsibility

Everyone

Quality Control Group

Part II: Train and Prepare for a Production Run

A. Lab Activity: Review the Lab Flow

Construct a flow diagram of the following overview of the training and production of your component for the snack product today.

Scenario: Your company, Awesome Snacks Company (ASC), needs you to produce popcorn for their seasonally available Summer Snack Mix. Your job will be to take the raw material and produce the popcorn that goes to the Snack Mixing Department.

1. Employee Overview

  • Supervisor (teacher) – Welcomes Employees (students) to Awesome Snack Company.
  • Overview of QMS and why it’s important to the company.

2. Group Formation

  • Divide employees up into Quality Assurance Teams (5 employees each team)

3. Training

  1. Supervisor gives training form (see figure below, in QA packet) and packets to team.
  1. Team Assigns Jobs to Members
    1. Material Control Tech.
    2. Quality Control Tech.
    3. Manufacturing Tech. I
    4. Manufacturing Tech II
    5. Quality Assurance Tech.
  2. QA Tech Reads SOP Standards 11-001 to team
  3. QA Tech distributes packets to each team member
    • Members read through their training packet
  4. Team completes ASC Training Document
  5. The completed ASC Training Document must be turned in to the supervisor (instructor) to receive material to start the production run.

4. Production

  1. Each technician performs their role
  2. Document everything on company forms
  3. Put the following calculation from ASC Form 004 into your laboratory notebook:
    • Percent weight loss for each of the three bags.
  4. Evaluate: Does batch meet specification?
    • Statistical Process Control: Mean, Standard Deviation, and Coefficient of Variation
  5. Post Production Product Specifications: Release or Reject
    • Are you accepting or rejecting this batch? Why?
  6. Once everything is completed, QA will turn forms into Supervisor

5. Corrective Action Plan

  1. Class discussion of Statistical Process Control
  2. Corrective and Preventative Action plan is constructed.

B. Activity: Training Using Good Manufacturing Practices (GMP)

PURPOSE: Every employee must be trained in conformance with GMP (Good Manufacturing Practices).

MATERIALS

  • 1 official SOP Standards for Employee Safety and Conduct: STANDARDS 11 -001 (see below)
  • 1 official Awesome Snack Company (ASC) Documentation of Training Document (see below)
  • 1 Set of the Standard Operating Procedures (SOPs) for Production: MAT-11-001, MAN-11-001, MAN-11-002, MAN-11-003, QA-11-001, QC-11-001
  • 1 set of production forms: ASC 001, ASC 002, ASC 003, ASC 004

PROCEDURE

Form Groups, Assign Roles, Complete Training
  1. The ideal group size is 5. Form groups and assign roles (jobs) to each member of Production Team. Jobs: Quality Assurance (QA), Quality Control (QC), Manufacturing Tech I, Manufacturing Tech II, Material Control (MC). Note: If the team is comprised of a group less than 5, 1 member must take multiple roles.
  2. Follow the training instructions below. After training, the documentation of training document (Figure 4) must be turned in to the supervisor (instructor) to receive material to start your production run.
Instructions:
  1. Quality Assurance (QA) Technician will read SOP Standards-11-001 to the Team.
  2. QA Technician distributes signs, SOPs and ASC Forms to each team member.
  3. Each team member reviews the scope and ASC guidelines, signs the page and receives a supervisor (or their designee) signature (see below)
  4. Each team member reads the SOP for his/her job to identify their primary activity. (Ex. Weigh unpopped popcorn (UPP))
  5. QA fills out table 2 below. In the order presented, QA lists the activity and asks the name of who will do it.
SCOPE
  • ALL ASC employees must be trained, acknowledge training, and receive sign-off from a supervisor.
  • Not following the stated ASC guidelines may result in written warning and/or termination of employment

The ASC Guidelines include but are not limited to the following:

  1. All hair that is shoulder length or longer must be tied back or contained in a hair net
  2. Fingernails must be neatly trimmed. Fingernails should not protrude past the ends of the fingertips more than ¼ inch
  3. Clothing and other personal belongings must be stored in designated areas
  4. All jewelry is prohibited in all manufacturing areas with the exception of one smooth ring (no stones) on finger. This includes and is not limited to watches, multiple rings, ear, nose, tongue, eye, belly piercings or rings...etc. are not allowed
  5. No items are allowed in pockets or affixed to clothing above the waist in the manufacturing area. The exception is for PPE (Personal Protective Equipment)
  6. Electronic devices such as cell phone, iPods, blue tooth, radio, pager, MP3, handheld games, etc. These items may be stored in lockers. Employees may use these devices only in designated areas during breaks, lunch, before and/or after work
  7. Areas must be left in a clean and organized manner at the end of each shift
  8. No food (including gum, candy, nuts and/or similar snacks) and/or drinks can be stored or consumed in manufacturing areas
  9. Every glass or plastic breakage in any manufacturing area must be reported to the Shift Supervisor or Safety Coordinator and a Quality Incident Report generated
  10. Use the following format for dates: Day-Month-Year (ex. 05-Mar-2019)
  11. When Initialing, use THREE initials, to include your middle initial

I, ___________________________ , certify that I have read and understand the ASC Guidelines.

Employee Full Name

Employee Signature

Supervisor Signature

Date

Date

Table 2. Assignment of Production Roles

ACTIVITY

WHO DOES THIS JOB? (NAME)

SOP/FORM

Inspect and/or Release, Reject UPP*

MAT-11-001 / ASC 002

Start Lot/Batch Record

QA-11-001 / ASC 001

Prepare and clean microwave/ balance

MAN-11-001, MAN-11-002, / ASC 003

Inspect Cleaning; OK production start

QC-11-001 / ASC 003

Weigh UPP

MAN-11-003 / ASC 004

Produce IPP*

MAN-11-003 / ASC 004

Place popcorn in Reject or Release

MAT-11-001 / ASC 002

Complete Lot/Batch Record

QA-11-001 / ASC 001

If necessary, initiate CAPA

*UPP= unpopped popcorn; IPP= in process popcorn

  1. Print name and Initial on the OFFICIAL Documentation of Training document (looks like below) after training on Standards and SOPs is complete. Be sure to include your middle initial
  2. Once completed, Material Control turns in the document in to Supervisor (Instructor) to receive the starting material (UPP) and start production
Table 3. Documentation of Training

JOB TITLE

NAME (Print)

INITIALS (Include Middle Initial)

Material Control Tech

Quality Control Tech

Manufacturing Tech I

Manufacturing Tech II

Quality Assurance Tech

This is similar to the official document to be used and completed during the exercise.

Part III: Production and Documentation

Perform Roles and Document Appropriately Using Company Forms

Procedure

      1. Use official company SOP documents to perform the assigned roles in Table 1.
      2. Document appropriately on the “official” Awesome Snack Company (ASC) forms as listed in Table 1

Results

ASC form 004 (IPP production report) is to be completed by your team and turned in to your supervisor (instructor) along with ASC forms 001, 002, 003.

Put the following calculations from this form into your laboratory notebook:

  1. Percent weight loss for each of the three bags. Are you accepting or rejecting this batch? Why?
  2. Statistical Process Control:
    • Mean:
    • Standard Deviation:
    • Coefficient of Variation:
  3. Post Production Product Specifications: Release or Reject

Study Questions

  1. Did you need to implement CAPA? Explain the deviance that caused this procedural process to begin and explain the corrective and preventative process you implemented. This will be shared with the class during discussion.
  2. The Ishigawa fishbone diagram (Figure 4) is a tool used to determine the root cause of a problem. It enables a team to brainstorm and categorize all the potential problems that could be the cause of a problem so they can be systematically eliminated until the real cause or causes is/are identified.
  3. With your team come up with all the potential reasons your popcorn may fail to meet quality specifications because it is burnt. Redraw the diagram, including the title, and fill it out in your laboratory notebook.

Vulnerability is considered a weakness in system security procedures, design, implementation, internal controls, and so on, that could be accidentally triggered or intentionally exploited and results in a violation of the systems' security policy 1 .

When the vulnerability is exploited, it results in a negative impact on the integrity of the e-records or availability of the electronic systems. Mitigation of the vulnerabilities in this context typically involves coding changes but could also include specification changes or even removal of affected functionality in their entirety.

There are six elements to evaluate the vulnerability of the electronic records (e-records) 2 : discovery, governance, cleansing, integration, security, and mastery. The assessment to each of these areas provides the required e-records integrity 3 controls to keep reliable the e-records after recreated.

The required e-records integrity controls to successfully manage the vulnerabilities can be categorized based on the event the erecords are performing in the e-records processing environment. These events are categorized as e-record creation, and during any operation such as processing, storing, while in transit, or retrieving. These events are contained in the data integrity (DI) definitions the in NIST 4 .

The Data as a service (DaaS) 5 will be used as the computer environment model to briefly discuss the vulnerabilities of the e-records. Any other model may be used as an example. The vulnerabilities to the e-records saved to electronic media are the same without considering the model.

DaaS builds on the concept that its e-records product can be provided to the regulated user 6 by a cloud service provider 7 on-demand, regardless of geographic or organizational separation between provider and consumer. In a DaaS service, the repository for e-records 8 and the e-records handling 9 are provided as a cloud service. E-records handling is a broader issue addressing potential erecords vulnerabilities. This distinction is important when evaluating technologies and the shifting roles of enterprise information technology (IT) when managing e-records in the DaaS cloud environments.

The objective of this article is to briefly discuss the areas to look at during the assessment of the e-records integrity vulnerabilities in a DaaS environment.

Out of the scope of this article is the electronic system's e-records integrity controls to effectively manage the vulnerabilities. Description of the e-records integrity controls can be found elsewhere 10 .

Fig. 1: Data and E-records Integrity in Process Automation


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1.20: Good Manufacturing Practices (GMPs) - Biology

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Efficient Gluten Testing

Food allergies affect an estimated 250 million consumers worldwide with more than 17 million in Europe alone. It is estimated that over 3% of adults and up to 6% of children have a food allergy . Although most food allergies cause relatively mild and minor symptoms, some can cause severe reactions and may even be life-threatening. Th erefore , when a food safety issue occurs due to mishandling of allergen-sensitive ingredients, the entire food processing industry suffers.

While the United States focuses on the “Big Eight” allergens (wheat (gluten) , crustacean shellfish, eggs, fish, peanuts, milk, tree nuts and soybeans) , Europe has expanded this list to 14 allergens, including those in the U.S. plus the addition of celery, mustard, sesame seeds, sulfur dioxide/ sulphites , lupin, and mollusk s. Both the U.S. and EU have provided guidance documents for food allergen labelling . Nevertheless, undeclared allergens continue to be a serious problem. This has forced food companies to implement not only Good Manufacturing Practices (GMPs) but also processe s to ensure protection from allergen cross-contact during manufacturing . Every attempt must be made to visibly identify allergens and isolate them at every step in the process, from raw ingredients and equipment to other foods housed and/ or are processed in the same facility.

With respect to one major allergen, gluten, detection has become even more complex. Gluten is defined as a complex mixture , composed of hundreds of related but distinct proteins , mainly prolamins and glutelins , and can be found in wheat, barley, rye, some oats and their crossbred varieties. It is mainly the prolamins, when digested into peptides, which trigger gluten sensitivity immune reactions, including Celiac Disease. The strongest immune response is to a prolamin fragment , an alpha2-gliadin fragment, referred to as a 33-mer or G-12. This fragment is highly resistant to breakdown by digestive enzymes, making it useful as an analytical marker in food products.

Since the only effective treatment for the celiac disease today is a gluten-free diet, this poses challenges to the food industry, as gluten is commonly found in many food products and additives. Plus, g luten-free products can have detectable levels of gluten due to cross-contamination during milling, storage, and/or production. To complicate matters , g luten detection in food is challenging because of the diversity of food matrices, protein levels or modifications , and the huge number of immunogenic sequences with differential potential immuno genicity . Therefore, it is essential to have accurate, rapid test methods for the detection of gluten in all types of foods.

Historically, ELISA was the recommended method for the detection of gluten in foo d and many commercial test kits are available. However, different test kits give varied results due to the unique specificities of the antibodies used and different extraction methods and materials for assay calibration. In addition, ELISA tests can prove to be costly and time-consuming. Lateral flow devices can offer similar results, but again depend on antibody specificity for detection of specific gluten antigens. While many antibodies have been developed, only a few have made it in to commercial tests.

One antibody, the Skerritt antibody, was raised against wheat gliadin and recognizes high molecular weight glutenin and omega-gliadins, so it can work for the detection of gluten in processed foods. However, quantitation is based on omega-gliadin levels , which differ among various cereals.

A second antibody, R5, was raised against rye, but shows cross-reactivity to wheat gliadin. In addition, it also detects soy and lupin proteins that are not harmful , leading to false-positive results which then require additional testing to confirm the presence or absence of gluten.

The best antibody option is the G12 antibody, which recognizes the 33-mer of the gliadin protein in gluten. It recognizes a specific amino acid sequence, found in wheat and detects similar peptides found in barley, rye and some varieties of oats. Therefore, it targets the specific fragment that triggers the autoimmune reaction found in celiac patients. It also does not cross-react with soy, maize, or rice, making it suitable for measuring gluten in products containing thes e ingredients.

Ideally, commercial kits for gluten detection should utilize the G12 antibody plus contain all the necessary reagents /components for testing food and food surfaces for the presence of gluten and other allergens. Plus , results should be obtained easily and quickly, so either processing can be quickly halted for cleaning or the product can be released as “gluten-free”. One such kit is GlutenTox ® Pro, a quick test for precise gluten detection. It can detect down to 5 ppm of gluten in wheat, barley, rye and some rare oat varieties within 20 minutes , far below regulatory levels. Provided as a “lab in a box” , it is designed to contain everything needed to conduct testing. In addition, it is AOAC PTM certified for m ultiple food matrices and environmental surfaces.

For other allergens, high-sensitivity and quick and reliable detection are essential too . One commercial product that meets these requirements is AlerTox ® Sticks. They can detect allergens in raw materials, final products and on working surfaces. AlerTox Sticks provide accurate results in 10 minutes with no need for special equipment . D etection levels range from 1 – 20 ppm, depending on the allergen. When combined with AllerSnap ™, food manufacturers can fe el confident that cleaning has removed residual protein, including potential allergens.

Other kits must be tested to see if they meet stringent food manufacturer allergen testing requirements, including low detection levels and no cross-reactivity to non-allergens. In the meantime, food manufacturers must be held responsible for ensuring their products are clearly labeled and free from allergens as claimed on the food label. It is vital that they use the most sensitive, specific immunochemical test systems available today – in the case of gluten, tests should be based on G12 antibody detection – in the case of other allergens, sensitivity and specificity, combined with ease of use, are essential.

“Recognition of gliadin and glutenin fractions in four commercial gluten assays.” Allred, LK, Ritter, BW. J AOAC Int. 2010 Jan-Feb93(1):190-6

“ Gluten Immunogenic Peptides as Standard for the Evaluation of Potential Harmful Prolamin Content in Food and Human Specimen .” Cebolla A., Moreno M de L , Coto L , and Sousa C. Nutrients. 2018 Dec 10(12): 1927 -42

“Sensitive detection of cereal fractions that are toxic to celiac disease patients by using monoclonal antibodies to a main immunogenic wheat peptide”. Morón B, Cebolla A, Manyani H, Alvarez- Maqueda M, Megías M, Thomas Mdel C, López MC, Sousa C. Am J Clin Nutr 2008 Feb87(2):405-14 .


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Since its inception in 2004, FDARegulatory.com has had one primary objective: be the Internet's most concise free resource of FDA regulations compliance information. In addition to recommending FDA compliance resources, we provide a Free FDA Regulations Information Library - a collection essential documents which outline ethical and scientific quality standards for designing and conducting operations in an FDA regulated environment. FDA regulations are mandatory standards because they are based on the regulations of the United States Code collectively, these standards make up the Code of Federal Regulations (CFR). Our focus is on this section of the CFR: "Title 21 CFR 820.25 - Personnel. (a) General. Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed." Through the use of our suggested reading material and affordable, all inclusive e-learning software, you can be compliant without spending a small fortune.

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GMP Training Package: Library Addition - 41% off MSRP through FDARegulatory.com

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"Widely used and accepted GMP training book which covers 21 CFR Part 11, Pharmaceutical Computer Validation Introduction, and Pharmaceutical Quality Control Lab. These three courses will give an excellent introduction to the most important areas of pharmaceutical manufacturing. When you successfully complete the exam, you will receive a certificate of completion that will demonstrate your mastery of this topic and provide documentation of GMP training. more

Investigations Operations Manual: FDA Field Inspection and Investigation Policy and Procedure Concise Reference

The IOM is the primary guidance document on FDA inspection policy and procedures for field investigators and inspectors. This extends to all individuals who perform field investigational activities in support of the Agency's public mission. Accordingly, it directs the conduct of all fundamental field investigational activities. Adherence to this manual is paramount to assure quality, consistency, and efficiency in field operations. The specific information in this manual is supplemented, not superseded, by other manuals and field guidance documents. The IOM is recommended reading for all operations regulated by the Food and Drug Administration. more

Electronic Record Keeping: Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164

The current revolution in software, and the regulations that have evolved to address it, have increasingly caused companies to turn to off-the-shelf software for electronic record keeping. Data captured in computerized systems must be as reliable, if not more so, than data on paper. Electronic Record Keeping: Achieving Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164 explores how to evaluate, select, implement, and document an e-system that will keep your organization in compliance. Covering Title 21 of the Code of Federal Regulations (CFR) Part 11 and the parallel, recently passed Title 45 CFR Parts 160, 162, and 164 of the Health Insurance Portability and Accountability Act . more

Designing A World-Class Quality Management System For FDA Regulated Industries: Quality System Requirements (QSR) For cGMP

"Quality System requirements for medical have been internationally recognized as a way to assure product safety and efficacy and customer satisfaction since at least 1983, and were instituted as requirements in a final rule published on October 7, 1996. source: Wikipedia . more

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GLP in the USA and EU

The United States Food and Drug Administration (FDA) has GLP rules in 21CFR58. In the US, people carrying out preclinical trials on animals use these rules. The FDA is America’s regulatory agency for medications, medical devices, food, cosmetics, and tobacco products.

In other words, researchers follow the rules before carrying out clinical research on humans.

If an organization does not follow the FDA rules or OECD Guidelines, it will find it hard to apply for a New Drug Application in the US. In fact, the New Drug Application in the US will probably stay on hold perpetually.

Since 1987, the European Council has adopted two basic Directives as well as a Decision related to the application of the GLP principles.

The rules and regulations regarding good laboratory practice in the EU apply across the whole economic bloc. Therefore, if a laboratory complied with the rules in one country, its processes are valid in all other EU member states.

When BREXIT happens, Britain will need to establish a relationship regarding GLPs with other countries. It will probably keep its current EU rules, and subsequently find a way of remaining within the EU umbrella. BREXIT stands for BRitain EXITing the European Union.


Watch the video: Good Manufacturing Practices GMP: Pharmaceutical Quality System (January 2022).