GMP Question and Answers
Why is GMP important?
Poor quality medicines are not only a health hazard, but a waste of money for both governments and individual consumers.
Poor quality medicines can damage health
A poor quality medicine may contain toxic substances that have been unintentionally added.
A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic effect.
GMP helps boost pharmaceutical export opportunities
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.
What is GMP?
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. GMP covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made. WHO has established detailed guidelines for good manufacturing practice. Many countries have formulated their own requirements for GMP based on WHO GMP. Others have harmonized their requirements, for example in the Association of South-East Asian Nations (ASEAN), in the European Union and through the Pharmaceutical Inspection Convention.
Is GMP necessary if there is a quality control laboratory?
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.
Can manufacturers afford to implement GMP?
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 works to strengthen GMP
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.
Why is GMP important?
Poor quality medicines are not only a health hazard, but a waste of money for both governments and individual consumers.
Poor quality medicines can damage health
A poor quality medicine may contain toxic substances that have been unintentionally added.
A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic effect.
GMP helps boost pharmaceutical export opportunities
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.
What is GMP?
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. GMP covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made. WHO has established detailed guidelines for good manufacturing practice. Many countries have formulated their own requirements for GMP based on WHO GMP. Others have harmonized their requirements, for example in the Association of South-East Asian Nations (ASEAN), in the European Union and through the Pharmaceutical Inspection Convention.
Is GMP necessary if there is a quality control laboratory?
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.
Can manufacturers afford to implement GMP?
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 works to strengthen GMP
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.
Good Manufacturing Practice (GMP) Resources
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.
GMP covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff. Detailed written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made.
GMP Resources
What is GMP?
GMP refers to the Good Manufacturing Practice regulations promulgated by the US Food and Drug Administration under the authority of the 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, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective.
GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. This protects the consumer from purchasing a product which is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time.
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.
GMP is also sometimes referred to as "cGMP". The "c" stands for "current," reminding manufacturers that they must employ technologies and systems which are up-to-date in order to comply with the regulation. Systems and equipment used to prevent contamination, mixups, and errors, which may have been first-rate 20 years ago may be less than adequate by current standards.
Good manufacturing practice
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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,[1] cosmetics,[2] pharmaceutical products,[3] dietary supplements,[4] and medical devices.[5] 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.[2] 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 that the product has been checked for quality more than just at the end phase.[2] GMP is typically ensured through the effective use of a quality management system (QMS).[1][2]
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, India and other countries.
High-level details[edit]
Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality assurance in order to ensure that a manufactured product is safe for human consumption or use. Many countries have legislated that manufacturers follow GMP procedures and create their own GMP guidelines that correspond with their legislation.
- 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.
Good manufacturing practices are recommended with the goal of safeguarding the health of consumers and patients as well as producing quality products. In the United States, a food or drug may be deemed "adulterated" if it has passed all of the specifications tests but is found to be manufactured in a facility or condition which violates or does not comply with current good manufacturing guideline.
GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be observed during manufacturing. When a company is setting up its quality program and manufacturing process, there may be many ways it can fulfill GMP requirements. It is the company's responsibility to determine the most effective and efficient quality process that both meets business and regulatory needs.[1][2]
Guideline versions[edit]
GMPs are enforced in the United States by the U.S. Food and Drug Administration (FDA), under Title 21 CFR. The regulations use the phrase "current good manufacturing practices" (CGMP) to describe these guidelines.[7][8][9][10] Courts may theoretically hold that a product is adulterated even if there is no specific regulatory requirement that was violated as long as the process was not performed according to industry standards.[11] However, since June 2007, a different set of CGMP requirements have applied to all manufacturers of dietary supplements, with additional supporting guidance issued in 2010.[4] Additionally, in the U.S., medical device manufacturers must follow what are called "quality system regulations" which are deliberately harmonized with ISO requirements, not necessarily CGMPs.[9]
The World Health Organization (WHO) version of GMP is used by pharmaceutical regulators and the pharmaceutical industry in over 100 countries worldwide, primarily in the developing world.[3] The European Union's GMP (EU-GMP) enforces similar requirements to WHO GMP, as does the FDA's version in the US. Similar GMPs are used in other countries, with Australia, Canada, Japan, Saudi Arabia, Singapore, Philippines, Vietnam and others having highly developed/sophisticated GMP requirements.[12] In the United Kingdom, the Medicines Act (1968) covers most aspects of GMP in what is commonly referred to as "The Orange Guide," which is named so because of the color of its cover; it is officially known as Rules and Guidance for Pharmaceutical Manufacturers and Distributors.[13]
Since the 1999 publication of GMPs for Active Pharmaceutical Ingredients, by the International Conference on Harmonization (ICH), GMPs now apply in those countries and trade groupings that are signatories to ICH (the EU, Japan and the U.S.), and applies in other countries (e.g., Australia, Canada, Singapore) which adopt ICH guidelines for the manufacture and testing of active raw materials.[12]
Enforcement[edit]
Within the European Union GMP inspections are performed by National Regulatory Agencies. GMP inspections are performed in Canada by the Health Products and Food Branch Inspectorate;[14] in the United Kingdom by the Medicines and Healthcare Products Regulatory Agency (MHRA);[15] in the Republic of Korea (South Korea) by the Ministry of Food and Drug Safety (MFDS);[16] in Australia by the Therapeutic Goods Administration (TGA);[17] in Bangladesh by the Directorate General of Drug Administration (DGDA);[18]; in South Africa by the Medicines Control Council (MCC);[19] in Brazil by the National Health Surveillance Agency (ANVISA);[20] in India by state Food and Drugs Administrations (FDA), reporting to the Central Drugs Standard Control Organization;[21] in Pakistan by the Drug Regulatory Authority of Pakistan;[22] in Nigeria by NAFDAC;[23] and by similar national organizations worldwide. Each of the inspectorates carries out routine GMP inspections to ensure that drug products are produced safely and correctly. Additionally, many countries perform pre-approval inspections (PAI) for GMP compliance prior to the approval of a new drug for marketing.
CGMP inspections[edit]
Regulatory agencies (including the FDA in the U.S. and regulatory agencies in many European nations) are authorized to conduct unannounced inspections, though some are scheduled.[7][13][16][17][18][19][21][22][23] FDA routine domestic inspections are usually unannounced, but must be conducted according to 704(a) of the Food, Drug and Cosmetic Act (21 USCS § 374), which requires that they are performed at a "reasonable time". Courts have held that any time the firm is open for business is a reasonable time for an inspection.[24]
Other good practices[edit]
Other good-practice systems, along the same lines as GMP, exist:
- Good agricultural practice (GAP), for farming and ranching
- Good clinical practice (GCP), for hospitals and clinicians conducting clinical studies on new drugs in humans
- Good distribution practice (GDP) deals with the guidelines for the proper distribution of medicinal products for human use.
- Good laboratory practice (GLP), for laboratories conducting non-clinical studies (toxicology and pharmacology studies in animals)
- Good pharmacovigilance practice (GVP), for the safety of produced drugs
- Good regulatory practice (GRP), for the management of regulatory commitments, procedures and documentation
Collectively, these and other good-practice requirements are referred to as "GxP" requirements, all of which follow similar philosophies. Other examples include good guidance practices, and good tissue practices
People who take supplements should be concerned with what’s in them. They should expect their supplements to be safe and contain quality ingredients. They should expect that what’s on the label is in the product.
Dietary supplement manufacturers must ensure that these legitimate expectations are consistently met, batch after batch. To achieve this goal, manufacturers need to adopt strict, risk-based practices and procedures for their manufacturing facility with a GMP (good manufacturing practice) facility registration. If issues arise, the GMP will be in place so the manufacturer can recognise, investigate and take appropriate planned action to protect the consumer and the marketplace from exposure to any potentially harmful ingredients or practices.
For decades, pharmaceutical companies have been required by law to have GMPs in place. They help ensure consistent, acceptable product quality and safety. An effective GMP reduces risk, helps companies save money, upholds a company’s reputation and helps to create a competitive edge in an increasingly crowded marketplace. The benefits of GMP are just as relevant to the dietary supplement industry as they are to the pharmaceutical industry.
One of the most critical components of GMP is quality control (QC)—the process of sampling, testing and comparing results with pre-agreed specifications as part of the overall quality assurance (QA) process. For supplement manufacturers, a well-designed QC system does not focus simply on finished product testing, but utilises the most appropriate analytical techniques to assure the quality of materials throughout the process.
To simplify this, GMP helps to ensure the consistent quality and safety of products by focusing attention on five key elements, which are often referred to as the 5 P’s of GMP—people, premises, processes, products and procedures (or paperwork). And if all five are done well, there is a sixth P … profit!
GMP refers to the Good Manufacturing Practice Regulations published by the FDA under the Federal Food, Drug, and Cosmetic Act. As a response to concerns about substandard drug manufacturing practices occurring at the time, Congress enacted the 1962 Drug Amendments. These amendments instructed the FDA to require all drugs to be made according to Good Manufacturing Practice (GMP) as defined under FDA 21 CFR Part 210-211.
The first set of Good Manufacturing Practices (GMP) regulations were published in 1963. These regulations are meant to guide companies in the production of safe and effective drugs. The regulations outlined in the GMPs are the minimum requirements necessary to ensure safe and effective products.
In this blog we'll discuss the definition of GMP, various regulatory components, and why it's important for companies in the life sciences space.
Trained inspectors for the FDA examine facilities around the world, including those facilities that produce the active ingredients and final products. The FDA also reviews consumer and industry complaints filed about the drug, using these reports to identify sites that could benefit from inspection.
About GMP
GMP is a set of regulations that ensures the quality of drugs, medical devices, blood, and some types of food. The regulations cover manufacturing, facilities and controls for the manufacturing, processing, packaging or holding of a drug product.
When discussing current good manufacturing practices, many agencies use the acronym cGMP, with the letter ‘c’ standing for ‘current.’ This nomenclature reminds companies to use the most up-to-date technologies and systems in order to comply with current regulations. Many older GMP practices, specifically those designed to prevent errors, mix-ups and contamination, are now outdated and inadequate.
About Part 210 and 211
21 CFR Part 210 and 211 outline the manufacture, processing, packing, or holding of a drug specifically, although supporting companies and services can benefit by compliance with these standards as well.
Part 210.2 applies to drug products intended for human use and lays out definitions for terms used within the document. Part 211 describes important issues.
Its 11 subparts discuss all sections of drug manufacturing operations:
- General Provision
- Organization and Personnel
- Building and Facilities
- Equipment
- Control of Components and Drug Product Containers and Closures
- Production and Process Controls
- Packaging and Labeling Controls
- Holding and Distribution
- Laboratory Controls
- Records and Reports
- Returned and Salvaged Drug Product
Each section of code outlines a different GMP activity. 211.22 details the responsibilities of a quality control unit, for example, while 211.25 discusses personnel qualifications, 211.28 deals with sanitation, clothing, protective apparel, hygiene and health habits and 211.34 offers guidelines on working with consultants. Part 1271 subparts C and D describes donor-eligibility and applicable current good tissue practice procedures for owners and operators of establishments engaged in the recovery, donor screening, donor testing and other types of testing, processing, storage, labeling, packaging, or distribution of human cells, tissue samples, and cellular and tissue-based products (HCT/Ps).
What GMP Means for Companies in the Life Sciences Space
GMP regulations address a wide range of production activities, including starting materials, sanitation and cleanliness of the premises, equipment verification, and process validation. GMP regulations even extend into human resources and general offices, offering practice guidelines for record keeping, personnel qualifications, complaints, training, and personal hygiene of staff working in regulated areas. GMP requires documented proof of consistent adherence to established procedures at every step in the production process.
While stringent in their requirement for quality, most GMP regulations are open-ended and flexible in that they allow individual companies the latitude to decide on the best way to implement the controls necessary to achieve the highest quality within each organization. Failure to comply with these regulations may result in regulatory action for the drug and for the company responsible for the failure.
Virtually every person in the United States is affected by the quality of pharmaceuticals. Nearly 70 percent of Americans take a prescription drug, according to Mayo Clinic, and almost half take two. The use of non-prescription or over-the-counter (OTC) drugs and supplements is also widespread. cGMPs are important because consumers cannot easily detect an unsafe or ineffective product simply by looking, smelling or touching it. GMP testing, typically performed on small samples from a batch, ensures that the rest of the batch provides the high quality medication or supplementation desired by these consumers.
Your work holds the potential to deliver life-changing treatments. Our mission is to help you succeed. Ensure the integrity of your valuable material – from collection and storage through delivery to patient – with customized, end-to-end supply chain management solutions.
What is good manufacturing practice (GMP)?
Good manufacturing practice (GMP) is a concept that ensures products are consistently produced and controlled according to quality standards. It is designed to minimize the risks to the patient involved in any pharmaceutical production.
GMP constitutes the license to operate in pharmaceutical manufacturing, and is a core condition worldwide. However, rules and interpretations differ from country to country and change frequently. Therefore, having fully trained experts at hand to help with the implementation of these rules is very important.
A basic outline of GMP
All guidelines follow a few basic principles:
- The production and distribution of the drugs must minimize any risk to their quality.
- Manufacturing facilities must maintain a clean and hygienic manufacturing area, including laboratories and storage.
- Manufacturing facility design, operating principles and environmental conditions must be controlled in order to prevent cross contamination of drug products, and to prevent cross contamination from labelled or unlabelled material or products.
- Manufacturing processes must be clearly defined, validated and controlled to ensure consistency and compliance with specifications. Any changes to the process are evaluated from a patient safety and product quality perspective, and any approved change that may affect the quality of the drug are qualified or validated as necessary.
- Instructions and procedures must be written in clear and unambiguous language (Good Documentation Practices).
- Operators should be trained to carry out the production and control of products according to documented and approved procedures.
- Records should be made during manufacture and quality control, 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 investigated and documented.
- The process should remain in a state of control throughout the product lifecycle and improvements done as needed.
- Records of manufacture (including distribution) are retained in a comprehensible and accessible format that can trace the complete history of a batch.
- A system must be available for recalling any batch from sale or supply.
- Complaints about marketed products should be examined, the causes of quality defects investigated, and appropriate measures taken with respect to the defective products and to prevent recurrence.
GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be applied during manufacturing. When a company is setting up its pharmaceutical quality system, manufacturing processes and control, there may be many ways to fulfil GMP requirements. It is the company's responsibility to determine the most effective and efficient quality process.
Why is GMP so important in pharma engineering?
Poor quality drugs can be a disaster for both patients and governments from a health and a cost perspective. If companies cannot manufacture appropriate quality products due to GMP issues (the most common reason) there is a high risk of drug shortage, which unfortunately affects patients who cannot get their prescribed medication when they need it. The pharmaceutical industry has a responsibility to ensure their safe and sufficient supply, and this must be taken into consideration in pharma engineering and consulting projects from the outset.
Additionally, GMP can help boost pharmaceutical export opportunities. The majority of countries worldwide only accept the import and sale of medicines that have been manufactured to internationally recognised GMP standards.
Investing in GMP means investing in quality medicine. It saves costs, minimizes risks, and improves the standard of drugs worldwide.
How can NNE help with GMP?
With our certified and pharmaceutically trained professionals, NNE offers you seamless, smart and compliant GMP and compliance solutions. We have the expertise and international experience to handle the increasingly complex risk-based GMP demands from early conceptual design, qualification and validation to practical development implementation and execution of a pharmaceutical quality system.
External resources
1. FDA
In the United States, Current Good Manufacturing Practices (cGMP) are the Food and Drug Administration's (FDA) formal regulations regarding the design, monitoring, control, and maintenance of manufacturing processes and facilities. The word "current" was added to signal to companies that they need to remain up to date with the latest technology rather than rely on what was a good practice 10 years ago.
Pharmaceutical and biotechnology companies follow cGMPs to ensure their items are manufactured to specific requirements including identity, strength, quality, and purity. Compliance is regulated by the Food and Drug Administration (FDA).
There are a number of federal regulations that relate to cGMP which, if not followed, can lead to criminal penalties. There are two specific regulations that relate to pharmaceutical manufacturers, one for biological products, and a regulation that monitors electronic records, counterparts, and electronic signatures.
In an excess of caution, some companies have opted to adopt practices, procedures, and risk management systems that go above and beyond cGMP regulations.
Code of Federal Regulations' Role in cGMP Regulations
The Code of Federal Regulations (CFR) is a codification of the general and permanent rules of the federal government. The CFR contains the complete and official text of the regulations that are enforced by federal agencies.
The CFR is divided into 50 titles that represent broad areas subject to federal regulations. Each title is divided into chapters assigned to various agencies issuing regulations pertaining to that broad subject area.
Each chapter is divided into parts covering specific regulatory areas. Each part or subpart is then divided into sections—the basic unit of the CFR. Sections are sometimes subdivided further into paragraphs or subsections. Citations pertaining to specific information in the CFR usually will be provided at the section level.
The Pharmaceutical Industry's cGMP Regulations
The CFRs that relate to cGMP in the pharmaceutical and biotechnology companies are:
- 21 CFR Part 210: Processing, Packing, or Holding of Drugs: In general, this governs cGMP for the manufacturing, processing, packaging, or holding of drugs. Part 210 includes the definitions that are used for terms in the regulations such as batch, lot, etc.
- 21 CFR Part 211: Finished Pharmaceuticals: This is for finished pharmaceuticals. For example, a liquid medication leaching through a plastic container would be covered by Part 210, but a pill breaking apart after it ships likely would be covered by Part 211.
- 21 CFR Part 600: Biological Products: This is related to biological products and contains key definitions, establishment standards, property inspection requirements, and adverse experience reporting requirements.
- 21 CFR Part 11: Electronic Records and Signatures: This contains the guidelines on electronic records and electronic signatures. Part 11 defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable, and equivalent to paper records. Part 11 also applies to submissions made to the FDA in electronic format.
The FDA's Role in cGMP Regulations
According to the FDA, one of the reasons drug manufacturing is regulated so strictly is to ensure uniformity across all products. A drug manufacturer may produce millions of pills, but only a fraction of a percent of them will be tested because doing so destroys them.
For this reason, it is important that all pills be manufactured under the same conditions and according to the same guidelines so consumers can be confident the pills being sold are identical to the pills being tested.