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Waste pharmaceuticals can affect the environment if they are not properly managed. Pharmaceuticals have been detected in water, sediments, and fish. We regulate businesses to ensure they properly manage waste pharmaceuticals.

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This document is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess.

This guidance is not intended to define registration and/or filing requirements or modify pharmacopoeial requirements. This guidance does not affect the ability of the responsible regulatory agency to establish specific registration/filing requirements regarding APIs within the context of marketing/manufacturing authorizations or drug applications. All commitments in registration/filing documents should be met.

This guidance excludes all vaccines, whole cells, whole blood and plasma, blood and plasma derivatives (plasma fractionation), and gene therapy APIs. However, it does include APIs that are produced using blood or plasma as raw materials. Note that cell substrates (mammalian, plant, insect or microbial cells, tissue or animal sources including transgenic animals) and early process steps may be subject to GMP but are not covered by this guidance. In addition, the guidance does not apply to medical gases, bulk-packaged drug (medicinal) products (e.g., tablets or capsules in bulk containers), or radiopharmaceuticals.

The use of dedicated production areas should also be considered when material of an infectious nature or high pharmacological activity or toxicity is involved (e.g., certain steroids or cytotoxic anti-cancer agents) unless validated inactivation and/or cleaning procedures are established and maintained.

Any production activities (including weighing, milling, or packaging) of highly toxic nonpharmaceutical materials, such as herbicides and pesticides, should not be conducted using the buildings and/or equipment being used for the production of APIs. Handling and storage of these highly toxic nonpharmaceutical materials should be separate from APIs.

The reserve sample should be stored in the same packaging system in which the API is stored or in one that is equivalent to or more protective than the marketed packaging system. Sufficient quantities should be retained to conduct at least two full compendial analyses or, when there is no pharmacopoeial monograph, two full specification analyses.

The number of process runs for validation should depend on the complexity of the process or the magnitude of the process change being considered. For prospective and concurrent validation, three consecutive successful production batches should be used as a guide, but there may be situations where additional process runs are warranted to prove consistency of the process (e.g., complex API processes or API processes with prolonged completion times). For retrospective validation, generally data from 10 to 30 consecutive batches should be examined to assess process consistency, but fewer batches can be examined if justified.

Validated analytical methods having sensitivity to detect residues or contaminants should be used. The detection limit for each analytical method should be sufficiently sensitive to detect the established acceptable level of the residue or contaminant. The method's attainable recovery level should be established. Residue limits should be practical, achievable, verifiable, and based on the most deleterious residue. Limits can be established based on the minimum known pharmacological, toxicological, or physiological activity of the API or its most deleterious component.

Analytical methods should be validated unless the method employed is included in the relevant pharmacopoeia or other recognized standard reference. The suitability of all testing methods used should nonetheless be verified under actual conditions of use and documented.

Active Pharmaceutical Ingredient (API) (or Drug Substance): Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.

FDA's portion of the CFR is in Title 21, which interprets the Federal Food, Drug and Cosmetic Act and related statutes, including the Public Health Service Act. The pharmaceutical or drug quality-related regulations appear in several parts of Title 21, including sections in parts 1-99, 200-299, 300-499, 600-799, and 800-1299.

The norms and standards for pharmaceuticals developed by WHO are prepared through a vast global consultative process involving WHO Member States, national regulatory authorities and international agencies; in consultation with the WHO Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations, specialists from industry, national institutions, nongovernmental organizations, and so on. These draft guidelines are evaluated during the meetings of the WHO Expert Committee on Specifications for Pharmaceutical Preparations and, if found suitable, are thereafter adopted as international standards.

This web page links to all current WHO norms and standards for pharmaceuticals guidelines which are grouped into (1) development, (2) production, (3) distribution, (4) inspection, (5) quality control, (6) regulatory standards and (7) specific texts for prequalification of medicines.

This document describes the suggested contents for the 3.2.P.2 (Pharmaceutical Development) section of a regulatory submission in the ICH M4 Common Technical Document (CTD) format. The guideline also indicates areas where the demonstration of greater understanding of pharmaceutical and manufacturing sciences can create a basis for flexible regulatory approaches.

For years the U.S. Department of Justice and the U.S. Department of Health and Human Services have pursued enforcement cases alleging inducement schemes through medical device and pharmaceutical company programs that pay physicians to talk about their products. Recently, the Office of the Inspector General at the Department of Health and Human Services detailed its position on these programs in a special fraud alert.

Although many companies won't welcome the OIG's specific callout of essential parts of their marketing plans, the special fraud alert provides a valuable window into the OIG's thinking and will allow companies engaged in these programs to better prepare for potential scrutiny from government enforcement authorities.

Although the government has pursued several cases against device and pharmaceutical company speaker programs, the special fraud alert marks the first time the OIG has detailed its specific concerns with these programs. Companies with speaker programs should therefore take note of the alert for several reasons.

The ISPE International Honor Awards program serves as a platform to celebrate the dedication and excellence of our members and their contributions to the pharmaceutical industry. The prestigious 2023 ISPE International Honor Award for Committee of the Year recognizes the remarkable achievements of ISPE's committees, councils, task teams, or communities of practice steering committees.

These new guidelines come at a time of intense legislative activity at the state and national level that seeks to limit the influence of pharmaceutical marketing on physicians. The wide array of policies put forth by industry, the medical profession, and government raise important questions about who should be relied upon at this point to limit the influence of marketing. In addition, if government intervention is warranted, what types of regulation are most likely to achieve this goal?

Meanwhile, within academic medicine there has been a steady movement to restrict pharmaceutical marketing activities at academic medical centers (AMCs). Many of these changes followed a policy proposal issued by a group of academic leaders14. Recently, the Association of American Medical Colleges (AAMC) endorsed a similar set of policies and several AMCs have begun to publicly disclose relationships with pharmaceutical companies15.

Independent of policy discussions concerning pharmaceutical promotion, public sector support of academic detailing programs makes sense to promote evidence-based prescribing. The pharmaceutical industry has mastered the art of influence - using these same techniques to encourage quality improvement could benefit patients and is worthy of public investment.

Even with these government approaches, self-regulation remains important and is not at odds with government regulation. Government regulations will contain loopholes and the pharmaceutical industry will find new ways to promote its products. Professional ethics and strong professional norms can better respond to complex and changing relationships and promote a stronger ethical foundation to enhance social trust.

What will it take for the medical profession to begin to clean its own house of ethically problematic industry relationships? The AMA guidelines do not seem to be a meaningful driver of professional change. Perhaps it is time for medical organizations to develop professional enforcement or reward mechanisms for compliance with ethical standards. For example, physician practices achieving a level of compliance could receive special professional recognition that would be on display to the public. In addition, professional medical societies could begin to provide leadership by weaning themselves of industry dependence as called for in a recent JAMA editorial52. 17dc91bb1f