Pharmaceutical Standards
Pharmaceutical standards are published by SDOs such as NSF, ISO, PDA, ASTM and others. They cover a wide variety of topics pertaining to pharmaceutical and drug manufacturing as well as best practices. A wide variety of standards from ASTM cover the manufacturing side of not only the drugs themselves, but also the medical devices that are required to administer specific life-saving drugs. The main standard on this topic is ASTM E2500-20, the Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment as well as its redline-commented version.
NSF/IPEC/ANSI 363-2019
Good Manufacturing Practices (GMP) for Pharmaceutical Excipients
This Standard is intended to define good manufacturing practices (GMP) for excipient manufacture and distribution3 for use in drug products
PDA PTC Isolators-2020
Points to Consider for the Aseptic Processing of Sterile Pharmaceutical Products in Isolators
This document is designed to communicate best practices and considerations and to encourage further dialog with industry, health authorities, and suppliers of technology and materials while taking into account the changes and needs of the modern, global, sterile, healthcare product manufacturing industry. In 2001, PDA issued Technical Report No. 34: Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products. Since then, much has been learned by industry, and several important regulatory guidelines, scientific articles, and conference presentations have been published. In an effort to address the impact of the knowledge gained, this task force was established to focus on important regulatory and technology updates impacting isolator design, validation, and operations for aseptic processing. Two primary types of isolators—open and closed—will be addressed in this Points to Consider (PtC) document (see Glossary). Additional related topics, such as sterility testing isolators and containment isolators, will be discussed in a separate PtC document in the future.
PDA TR 67-2014
Exclusion of Objectionable Microorganisms from Nonsterile Pharmaceuticals, Medical Devices, and Cosmetics
The scope of this technical report is the exclusion of objectionable microorganisms from nonsterile pharmaceutical drug products, over-the-counter (OTC) drug products; medical devices; cosmetics; and personal care products in the pharmaceutical, medical device, cosmetics and consumer healthcare industries (referred to as “our industry” in the remainder of this report).
ASTM E2500-20
Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
1.1 This guide is applicable to all elements of pharmaceutical and biopharmaceutical manufacturing systems including: good manufacturing practice (GMP) utility equipment, process equipment, supporting utilities, associated process monitoring and control systems, and automation systems that have the potential to affect product quality and patient safety.
1.2 For brevity, these are referred to throughout the rest of this guide as manufacturing systems.
1.3 This guide may also be applied to laboratory, information, and medical device manufacturing systems.
1.4 This guide is applicable to both new and existing manufacturing systems. The approach may be used for implementation of changes to existing systems.
1.5 This guide is applicable throughout the life-cycle of the manufacturing system from concept to retirement.
1.6 This standard does not address employee health and safety, environmental, or other non-GxP regulations. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
ASTM E3263-20
Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues
1.1 This practice provides statistically valid procedures for determining the visual detection limit of residues and the qualification of inspectors to perform the visual inspection of pharmaceutical manufacturing equipment surfaces and medical devices for residues.
1.2 This practice applies to pharmaceuticals [including active pharmaceutical ingredients (APIs); dosage forms; and over-the-counter, veterinary, biologics, and clinical supplies] and medical devices following all manufacturing and cleaning. This practice is also applicable to other health, cosmetics, and consumer products.
1.3 This practice applies to all types of chemical residues (including APIs, intermediates, cleaning agents, processing aids, machining oils, and so forth) that could remain on manufacturing equipment surfaces or medical devices that have undergone all manufacturing steps including cleaning.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
ONORM EN ISO 21676:2022
Water quality - Determination of the dissolved fraction of selected active pharmaceutical ingredients, transformation products and other organic substances in water and treated waste water - Method using high performance liquid chromatography and mass spectrometric detection (HPLC-MS/MS or -HRMS) after direct injection (ISO 21676:2018)
This document sets a method for determining the dissolved proportion of selected drugs and transformation products as well as other organic substances (see Table 1) in drinking, basic, surface and treated wastewater. The lower scope of the method may vary depending on the sensitivity of the devices used and the matrix of the sample. For most connections for which this document is used, the range is greater than or equal to 0.025 g / l in drinking, base and surface water and greater than or equal to 0.050 g / l in treated wastewater. The method can be used to determine further organic substances or in other types of water (eg, thereto), if correctness in individual cases has been tested and detected and the storage conditions of samples and reference solutions were validated.
NSF/IPEC/ANSI 363-2016
Good Manufacturing Practices (GMP) for Pharmaceutical Excipients
The principles outlined in this Standard provide a comprehensive basis for the quality management system used in the manufacture of pharmaceutical excipients.
NSF/ANSI 455-4-2022
Good Manufacturing Practices for Over-the-Counter Drugs
This standard is intended to define a standardized approach for auditing to determine the level of compliance of over-the-counter (OTC) drug products to 21 CFR Part 210 and 21 CFR Part 211, International Council for Harmonisation of Technical Requirements for Pharmaceutical for Human Use (ICH) Quality Guidelines, 1, 7 and 10, as well as incorporating additional retailer requirements.
PDA TR 53-2011
Guidance for Industry: Stability Testing to Support Distribution of New Drug Products
The objective of this Technical Report: Guidance for Industry: Stability Testing to Support Distribution of New Drug Products is to describe and justify the studies using scientific data and rationale necessary to determine an appropriate stability budget for a drug product. This is the first of seven categories, or pillars, of Good Distribution Practices (GDPs).
ISO 20072:2009
Aerosol drug delivery device design verification - Requirements and test methods
ISO 20072:2009 applies to the design, labelling, instructions for use and testing requirements for hand-held single- and multi-use aerosol drug delivery devices (ADDDs) intended to deliver a metered or pre-metered aerosolized medication to or by means of the human respiratory tract (including nasal, oral, tracheal, bronchial and alveolar sites). This International Standard applies to both refillable and disposable devices intended for personal use.
ISO 20072:2009 is intended for device design verification and not for drug product quality assessment. The objective of this International Standard is to verify, by laboratory (in-vitro) testing, that the ADDD design consistently meets the manufacturer's design specification by satisfying a device functionality profile and system verification test both of which are determined from a risk assessment and evaluated in accordance with the instructions for use.
