GLOSSARY

DEFINITION	DESCRIPTION	REF:
Acceptance criteria (general)	Measurable terms under which a test result may be considered acceptable. (Most common definition)
Acceptance criteria (in reference to equipment and system)	A pre-determined set of equipment performance parameters based on the limitations and requirements of the equipment and the test to be performed on it and considered critical to the qualification of the equipment.
Acceptance criteria (in reference to equipment and system)	The criteria that a system or component must satisfy in order to be accepted by a user or other authorized entity	2.3
Acceptance criteria (in reference to product)	The acceptable limits of a GMP Critical Parameter to ensure product SISPQ (Strength, Identity, Safety, Purity, or Quality)
Acceptance criteria (in reference to product)	Means the product specifications and acceptance/rejection criteria, such as acceptable quality level and unacceptable quality level, with an associated sampling plan, that are necessary for making a decision to accept or reject a lot or batch (or any other convenient subgroups of manufactured units).	2.1
Air Change Rate	The number of times the total air volume of a defined space is replaced in a given unit of time. This is computed by dividing the total volume of the subject space (in cubic feet) into the total volume of air exhausted from (or supplied to) the space per unit of time.	2.3
Airborne Particulate Cleanliness Classes	Statistically allowable number of particles equal to, or larger than 0.5µm in size per cubic foot of air. According to ISO 14644-1, a classification number, N, shall designate airborne particulate cleanliness.	2.3
Airlock	A room or space designed to act as a means of segregating areas of different air classification or quality. It may contain a method to remove particulate contamination from clean room garments as personnel pass through, and usually includes HEPA filtered air supply and interlocking doors. Airlocks pressure will “float” between those of the spaces being protected. With all doors closed, the airlock pressure will be somewhere between that of the highest adjoining room and that of the lowest adjoining room as air flows through it from room to room. “Ventilated airlocks” are in neutral ducted air balance (supply CFM = return CFM).	2.3
Alarms	Audible or visual signals used to warn of unacceptable conditions at monitored sites. They may be buzzers, horns, speakers, bells, or warning lights. They can be Advisory, Alert, or Action alarms. The first two are for operation and maintenance information, to alert of abnormal situations that do not compromise product SISPQ. The Action alarm is for GMP records, indicating that product SISPQ may have been compromised, but Alert alarms are also usually recorded.	2.3
Alert Point	Used in determining when a parameter is drifting toward extremes of the operating range.	2.3
Analytical Method	Small scale process used to characterize and/or separate a mixture, a compound, or an unknown material into its constituent parts or elements.	2.3
Annual Review	An evaluation, conducted at least annually, that assesses the quality standards of each drug product to determine the need for changes in drug product specifications or manufacturing or control procedures	2.4
Batch	a specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture	2.1
Batch – Lot number, control number, or batch number	any distinctive combination of letters, numbers, or symbols, or any combination of them, from which the complete history of the manufacture, processing, packing, holding, and distribution of a batch or lot of drug product or other material can be determined.	2.1
CAPA	Corrective and preventive action: A systematic approach that includes actions needed to correct (“correction”), prevent recurrence (“corrective action”), and eliminate the cause of potential nonconforming product and other quality problems (preventive action) (21CFR 820.100)	2.4
Commissioning	A well-planned, documented, and managed engineering approach to the start-up and turnover of facilities, systems, and equipment to the end-user that results in a safe and functional environment that meets established design requirements and stakeholder expectations (ISPE Pharmaceutical Engineering Jul/August 2008)	2.6
Component	any ingredient intended for use in the manufacture of a drug product, including those that may not appear in such drug product	2.1
Continuous Improvement	Ongoing activities to evaluate and positively change products, processes, and the quality system to increase effectiveness	2.4
Correction	Repair, rework, or adjustment relating to the disposition of an existing discrepancy.	2.4
Corrective Action (Deviation)	Action taken to eliminate the causes of an existing deviation or discrepancy or other undesirable situation to prevent recurrence. Examples of corrective actions: adjustments made to equipment to correct the deviation, segregation of defective units. Refer Q07-8001 Deviation Reporting Procedure.	2.4
Critical Aspects	Critical aspects of manufacturing systems are typically functions, features, abilities, and performance or characteristics necessary for the manufacturing process and systems to ensure consistent product quality and patient safety. They should be identified and documented based on scientific product and process understanding.	2.3
Critical Quality Attributes (CQA) Critical Process Parameters (CPP) Customer	A physical, chemical, biological or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality. SOURCE: ICH Q8 Pharmaceutical DevelopmentA process parameter whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled to ensure the process produces the desired quality. SOURCE: ICH Q8 Pharmaceutical Development A person or organization (internal or external) that receives a product or service anywhere along the product’s life cycle	2.4
Design reviews Deviation from cGMP	Are planned and systematic reviews of specifications, design, and design development and continuous improvement changes performed as appropriate throughout the life-cycle of the manufacturing system. Design reviews evaluate deliverables against standards and requirements, identify problems, and propose required corrective actions An event requiring further investigation as it may affect the identity, strength, efficacy quality, safety, purity, or potency of a product and/or may have regulatory implications. Refer Q07-8001 Deviation Reporting Procedure. Planned deviations are action plans that are used in anticipated or on a temporary basis to remediate a situation.	2.3
Direct Impact System	The design and operation of an equipment or system that is expected to have a direct impact on product quality. These systems are designed and commissioned in line with Good Engineering Practice, and in addition, are subject to Qualification practices that incorporate the enhanced review, control, and testing against specifications or other requirements necessary for GxP compliance.An example is piping which has direct contact with the in-process material or product. Indirect Impact System A system that is not expected to have a direct impact on product quality, but typically will support a Direct Impact System. These systems are designed and commissioned following Good Engineering Practice only. No Impact System System that will not have any impact, either directly or indirectly, on product quality. These systems are designed and commissioned following Good Engineering Practice only.	2.6
Discrepancy	Datum or result outside of the expected range; an unfulfilled requirement; may be called non-conformity, defect, deviation, out-of-specification, out-of-limit, out-of-trend	2.4
Document	Any combination of text, graphics, data that can be used to clearly and completely recreate an activity, event or process. Documentation in this procedure shall mean GMP Documents
Drug	Means a finished dosage form, for example, tablet, capsule, solution, etc., that contains an active drug ingredient generally, but not necessarily, in association with inactive ingredients. The term also includes a finished dosage form that does not contain an active ingredient but is intended to be used as a placebo.	2.1
Engineering Specifications	A legally binding, comprehensive, easy to follow set of instructions, statements and practices to procure materials and workmanship for building, installation and execution of engineering projects	2.6
Engineering Standards	Mandatory minimum requirements presented in a flexible format fitting the topic, that apply to new construction projects and improvements in design, construction, and testing. Engineering Standards represent value-added, cost-effective applications as well as efficient operation and maintenance practices.	2.6
Equipment Qualification	Qualification means the process to demonstrate the ability to fulfill specified requirements.EQ – Action of proving and documenting that equipment or ancillary systems are properly installed (Installation Qualification), work correctly (Operations Qualification OQ), and the different sub-systems work together as a system (Performance Qualification PQ) and actually lead to the expected results. Qualification is part of validation, but the individual qualification steps alone do not constitute process validation.	2.6
Event (Deviation)Filter – Non-fibre-releasing filter	An “event” (in regard to Deviation) is an incident that represents potential departure from cGMP or has an impact to product quality. For multiple events which occur during the processing of a single batch of product then each event must be captured under a separate Notice of Event (NOE). Any filter which after any appropriate pretreatment such as washing or flushing, will not release fibres into the component or drug product that is being filtered. All filters composed of asbestos are deemed to be fibre-releasing filters.	2.1
Filter – Fibre	Any particulate contaminant with a length at least three times greater than its width.	2.1
FMCG	FMCG is an acronym for Fast Moving Consumer Goods which means ‘things you buy on a regular basis at places like your local supermarket.’ Examples are butter, potato chips, toothpaste, and razors. It is also referred to as the grocery industry or CPG (Consumer packaged goods). Source: NZ Food & Grocery Council.
GMP	Good manufacturing practice (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.GMP is aimed primarily at diminishing the risks inherent in any pharmaceutical production, which may broadly be categorized in two groups: cross contamination/mix-ups and false labelling. Above all, manufacturers must not place patients at risk due to inadequate safety, quality or efficacy; for this reason, risk assessment has come to play an important role in WHO quality assurance guidelines.	2.2
GMP Document	Documents generated during a process with the purpose of delivering and proving GMP compliance. They are required to be formally approved and archived.Documentation includes GMP records and Lifecycle GMP Documents.
GMP Facility	A production facility or clinical trial materials pilot plant for the manufacture of pharmaceutical products. It includes the manufacturing space, the storage warehouse for raw and finished product, and support laboratory areas.A GMP facility operates under the guidelines established by regulatory authorities and guidelines eg FDA CFR (Code of Federal Regulations).
GMP Project	A project where the activities and deliverables are carried out in a GMP environment and have the potential to affect the quality of the products manufactured in the facility.
Good Documentation Practice	The handling of written or pictorial information describing, defining, specifying and/or reporting of certifying activities, requirements, procedures or results in such a way as to ensure data integrity.
Good Engineering Practice (GEP)	GEP is defined as those established engineering methods and standards that are applied throughout the life cycle to deliver appropriate and effective solutions.
Harm	Damage to health, including the damage that can occur from the loss of product quality or availability	2.4
I C H	International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use
Ingredient – Active Pharmaceutical Ingredient API	Any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect.	2.1
Ingredient – Inactive ingredient	any component other than an active ingredient.	2.1
Initial (to a Name)	The first letter of each word of one’s name, a simplified version of one’s signature or the same as one’s signature. Initials and date acceptable for review steps or corrections.
In-process material	Any material fabricated, compounded, blended, or derived by chemical reaction that is produced for, and used in, the preparation of the drug product.	2.1
Installation Qualification (IQ)	For “Direct Impact” systems, the documented verification that all aspects of a facility, utility or equipment that can affect product quality adhere to approved specifications (e.g., construction, materials) and is correctly installed. This includes adherence to appropriate GMPs and product criteria, approved design intentions, and manufacturer’s recommendations.	2.6
Labelling – Gang-printed labelling	Means labelling derived from a sheet of material on which more than one item of labelling is printed.	2.1
Legacy	A Legacy System should be considered to be any GxP relevant system that is in place and in use, and which is deemed not to satisfy current regulatory expectations (Source: ISPE GAMP Good Practice Guide (GPG))	2.6
Lifecycle GMP Document	It is a document that may undergo revision and re-issuance such as procedure, specification, master record and form.
Lifecycle GMP Form	Lifecycle GMP Form is a printed or typed, paper or electronic document, with blank spaces for insertion of required or requested information which, when information is entered, becomes a GMP record.
Lot	a batch, or a specific identified portion of a batch, having uniform character and quality within specified limits; or, in the case of a drug product produced by continuous process, it is a specific identified amount produced in a unit of time or quantity in a manner that assures its having uniform character and quality within specified limits.	2.1
Manufacture, processing, packing, or holding of a drug product	Includes packaging and labelling operations, testing, and quality control of drug products.	2.1
Manufacturing systems	Are elements of pharmaceutical and biopharmaceutical manufacturing capability, including facility 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	2.3
Medicated feed	Means any Type B or Type C medicated feed as defined in 558.3 of this chapter. The feed contains one or more drugs as defined in section 201(g) of the act. The manufacture of medicated feeds is subject to the requirements of part 225 of FDA 21 CFR chapter.	2.1
Medicated premix	Means a Type A medicated article as defined in 558.3 of this chapter. The article contains one or more drugs as defined in section 201(g) of the act. The manufacture of medicated premixes is subject to the requirements of part 226 of FDA CFR chapter 21	2.1
Non-conformity	A deficiency in a characteristic, product specification, process parameter, record, or procedure that renders the quality of a product unacceptable, indeterminate, or not according to specified requirements	2.4
Operational Qualification (OQ)	For “Direct Impact” systems, the documented verification that all aspects of a facility, utility, or equipment that can affect product quality, perform as intended throughout all anticipated operating ranges.	2.6
Performance Qualification (PQ)	Documented evidence that a complex system of multiple qualified components performs as required, when operated in an integrated manner over the expected range of operating conditions. PQ is performed when a system requires an extended monitoring program or other challenge.	2.6
PICS	PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PICS http://www.picscheme.org
Preventive Action (Deviation)	Action taken to eliminate the cause of a potential discrepancy or other undesirable situation to prevent such an occurrence. That is, actions taken to prevent a deviation or a recurrence of a deviation. Examples of preventive actions: updates to existing procedures, development of new policy/programs/procedures, notification or action by other departments, process improvements, automated controls, etc. Refer Q07-8001 Deviation Reporting Procedure.	2.4
Product/Service	The intended results of activities or processes; products/services can be tangible or intangible	2.4
Product Realization	Product Realization (ISO-9001-2000) refers to a set of related processes that are used to bring a product from conceptual to being.	2.5
Project Quality Plan	Defined as a set of activities planned at the beginning of a project that helps achieve Quality in the Project being executed. The Purpose of the Project Quality Plan is to define these activities / tasks that intends to deliver products while focussing on achieving customer’s quality expectations. These activities / tasks are defined on the basis of the quality standards set by the organization delivering the product.
Qualification	See Equipment Qualification	2.6
Qualification Protocols	An individual detailed document that describes the system under consideration, testing plans, acceptance criteria and test results that ensure that a system is installed and operates in accordance with predetermined specifications.	2.6
Quality	A measure of a product’s or service’s ability to satisfy the customer’s stated or implied needs.	2.4
Quality Assurance	Proactive and retrospective activities that provide confidence that requirements are fulfilled	2.4
Quality Control	The steps taken during the generation of a product or service to ensure that it meets requirements and that the product or service is reproducible	2.4
Quality control unit	Means any person or organizational element designated by the firm to be responsible for the duties relating to quality control.	2.1
Quality Management	Accountability for the successful implementation of the quality system	2.4
Quality Objectives	Specific measurable activities or processes to meet the intentions and directions as defined in the quality policy	2.4
Quality Plan	The documented result of quality planning that is disseminated to all relevant levels of the organization. Also see “Project Quality Plan” definition above.	2.4
Quality Planning	A management activity that sets quality objectives and defines the operational and/or quality system processes and the resources needed to fulfill the objectives	2.4
Quality Policy	A statement of intentions and direction issued by the highest level of the organization related to satisfying customer needs. It is similar to a strategic direction that communicates quality expectations that the organization is striving to achieve.	2.4
Quality System	Formalized business practices that define management responsibilities for organizational structure, processes, procedures, and resources needed to fulfill product/service requirements, customer satisfaction, and continual improvement	2.4
Quality Unit	A group organized within an organization to promote quality in general practice	2.4
Record	Documentation of specific activities that take place during the manufacture, processing, packaging, testing, holding and distribution of drug products, actives and intermediates. Records include original documents, true copies such as photocopies, facsimile, or other accurate reproductions of the original records. Records may also include electronic file, reports and data.
Representative sample	Means a sample that consists of a number of units that are drawn based on rational criteria such as random sampling and intended to assure that the sample accurately portrays the material being sampled.	2.1
Risk	– The combination of the probability of occurrence of harm and the severity of that harm	2.4
Risk Assessment	A systematic process for organizing information to support a risk decision that is made within a risk management process. The process consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards.	2.4
Risk Assessment (Equipment & System)	A methodology, conducted during the design of the facility, to determine, analyse, and manage potential risks to product quality (ISPE Active Pharmaceutical Ingredients Baseline® Guide Second Edition, June 2007)	2.6
Risk ManagementRoot Cause Analysis (Deviation)	The systematic application of quality management policies, procedures, and practices to the tasks of assessing, controlling, communicating, and reviewing risk To determine the most probable cause of an event/deviation by systematically eliminating all other potential root causes and rationale.	2.4
Senior Management	Top management officials in a firm who have the authority and responsibility to mobilize resources.	2.4
Signature (Name)	The act of signing one’s name with a distinctive characteristic to indicate identity.
Stakeholder	An individual or organization having an ownership or interest in the delivery, results, and metrics of the quality system framework or business process improvements	2.4
Strength	Means:(i) The concentration of the drug substance (for example, weight/weight, weight/volume, or unit dose/volume basis), and/or (ii) The potency, that is, the therapeutic activity of the drug product as indicated by appropriate laboratory tests or by adequately developed and controlled clinical data (expressed, for example, in terms of units by reference to a standard).	2.1
Validation	Confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled. (Reference: The ASQ Auditing Handbook, 3rd edition, ASQ Quality Audit Division, J.P. Russell, Editor)	2.4
Verification	A systematic approach to verify that manufacturing systems, acting singly or in combination, are fit for intended use, have been properly installed, and are operating correctly. This is an umbrella term that encompasses all types of approaches to assuring systems are fit for use such as qualification, commissioning and qualification, verification, system validation, or other.	2.3
Verification	Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled. (Reference: The ASQ Auditing Handbook, 3rd edition, ASQ Quality Audit Division, J.P. Russell, Editor)	2.4
Yield – Actual yield	Means the quantity that is actually produced at any appropriate phase of manufacture, processing, or packing of a particular drug product.	2.1
Yield – Theoretical yield	Means the quantity that would be produced at any appropriate phase of manufacture, processing, or packing of a particular drug product, based upon the quantity of components to be used, in the absence of any loss or error in actual production.Percentage of theoretical yield means the ratio of the actual yield (at any appropriate phase of manufacture, processing, or packing of a particular drug product) to the theoretical yield (at the same phase), stated as a percentage.	2.1

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REFERENCES

2.1 FDA 21 CFR PART 210

cGMP in manufacturing, processing, packing or holding of drugs
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=210&showFR=1

2.2 World Health Organization

http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/

2.3 ASTM E2500-07

Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing System and Equipment

2.4 FDA Guidance for Industry

Quality Systems Approach to Pharmaceutical CGMP Regulations, September 2006

2.5 ISO 9001-2000 Quality management system – Requirements

2.6 ISPE (International Society of Pharmaceutical Engineering)

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REGULATORY STANDARDS

3.1 FDA

• 21 CFR Part 1 – General enforcement regulations
• 21 CFR Part 2 – General Administration Rulings and Decisions
• 21 CFR Part 3 – Product jurisdiction
• 21 CFR Part 5 – Organisation
• 21 CFR Part 7 – Enforcement policy
• 21 CFR Part 11 (US ERES) – Electronic Records; Electronic Signatures
• 21 CFR Part 50 (US GCP) – Protection of human subjects
• 21 CFR Part 54 (US GCP) – Disclosure by clinical investigations
• 21 CFR Part 56 (US GCP) – Institutional review boards
• 21 CFR Part 58 (US GLP) – Good laboratory practice for non-clinical laboratory studies
• 21 CFR Part 110 – current good manufacturing practice in manufacturing, packing, or holding human food
• 21 CFR Part 200 – General
• 21 CFR Part 203 (US PDMA) – Prescription drug marketing
• 21 CFR Part 210 (US GMP) – Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs; general
• CFR Part 211 (US GMP) – Current good manufacturing practice for finished pharmaceuticals
• CFR Part 226 – current good manufacturing practice for type a medicated articles
• CFR Part 312 (US GCP) – Investigational new drug application
• CFR Part 314 (US GCP) – Applications for FDA approval to market a new drug
• CFR Part 600 (US Biologics) – Biological products – General
• CFR Part 601 (US Biologics) – Licensing
• CFR Part 606 – current good manufacturing practice for blood and blood components
• CFR Part 610 (US Biologics) – General biological products standards
• CFR Part 807 – Establishment registration and device listing for manufacturing and initial importers of devices
• 21 CFR Part 812 (US Devices) – Investigational device exemptions
• 21 CFR Part 814 (US Devices) – Pre-market approval of medical devices
• 21 CFR Part 820 (US QSR) – Quality system regulation
• 21 CFR Part 861 – Procedures for performance standards development
• Sarbanes Oxley Act 2002

3.2 EUROPEAN UNION (EU)

• GDP 94/C 63/03 – Guidelines on Good Distribution Practice of Medicinal Products for Human Use
• EU Directive 178/2002 – Directive laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety
• EU Directive 1935/2004 – materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC
• EU Directive 91/412/EEC – Laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products
• EU Directive 93/42/EEC – 14 June 1993 concerning medical devices
• EU Directive 1999/93/EC – Community framework for electronic signatures
• EU Directive 2001/20/EC – Implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
• EU Directive 2001/83/EC – Community code relating to medicinal products for human use
• EU Directive 2001/95/EC – General Product Safety
• EU Directive 2002/95/EC – Restrictions of the use of hazardous substances in electrical and electronic equipment
• EU Directive 2002/96/EC – Where a computerised system replaces a manual operation
• EU Directive 2002/98/EC – Amending Directive 2001/83/EC
• EU Directive 2003/63/EC – Amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use
• EU Directive 2003/94/EC – Laying down principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use
• EU Directive 2004/23/EC – Standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells
• EU Directive 2004/24/EC – Amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use
• EU Directive 2004/27/EC – Amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (Text with EEA relevance)
• EU Directive 2005/28EC – principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use
• Eudralex Volume 4: Part 1 – Basic Requirements for Medicinal Products

o Chapter 1 – Quality Management
o Chapter 2 – Personnel
o Chapter 3 – Premise and Equipment
o Chapter 4 – Documentation
o Chapter 5 – Production
o Chapter 6 – Quality Control
o Chapter 7 – Contract Manufacturing and Analysis
o Chapter 8 – Complaints and Product Recall
o Chapter 9 – Self Inspection

• Eudralex Volume 4: Part 2 – Basic Requirements for Active Substances used as Starting Materials
• Annex 1 – Manufacture of Sterile Medicinal Products
• Annex 2 – Manufacture of Biological Medicinal Products for Human Use
• Annex 3 – Manufacture of RadioPharmaceuticals
• Annex 4 – Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products
• Annex 5 – Manufacture of Immunological Veterinary Medicinal Products
• Annex 6 – Manufacture of Medicinal Gases
• Annex 7 – Manufacture of Herbal Medicinal Products
• Annex 8 – Sampling of Starting and Packaging Materials
• Annex 9 – Manufacture of Liquids, Creams and Ointments
• Annex 10 – Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation
• Annex 11 – Computerised Systems
• Annex 12 – Use of Ionising Radiation in the Manufacture of Medicinal Products
• Annex 13 – Manufacture of Investigational Medicinal Products
• Annex 14 – Manufacture of Products derived from Human Blood or Human Plasma
• Annex 15 – Qualification and validation
• Annex 16 – Certification by a Qualified person and Batch Release
• Annex 17 – Parametric Release
• Annex 19 – Reference and Retention Samples (EU Directive 2003/94/EC / EU Directive 91/412/EEC )

3.3 UNITED KINGDOM

• S.I. 2005/2789 – The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005
• S.I. 2005/2789 (Schedule 1) – STANDARD PROVISIONS WHICH MAY BE INCORPORATED IN A MANUFACTURER’S LICENCE RELATING TO THE MANUFACTURE AND ASSEMBLY OF RELEVANT MEDICINAL PRODUCTS
• S.I. 2005/2789 (Schedule 2) – STANDARD PROVISIONS WHICH MAY BE INCORPORATED IN A MANUFACTURER’S LICENCE RELATING TO THE IMPORT OF RELEVANT MEDICINAL PRODUCTS FROM A THIRD COUNTRY
• S.I. 2005/2789 (Schedule 3) – STANDARD PROVISIONS WHICH MAY BE INCORPORATED IN A MANUFACTURER’S LICENCE WHICH RELATES TO VACCINES, TOXINS OR SERA
• S.I. 2005/2789 (Schedule 4) – STANDARD PROVISIONS WHICH MAY BE INCORPORATED IN A WHOLESALE DEALER’S LICENCE
• S.I. 2005/2789 (Schedule 5) – CONSEQUENTIAL AND OTHER AMENDMENTS OF ENACTMENTS
• S.I. 2005/2789 (Schedule 6) – TRANSITIONAL PROVISIONS

3.4 JAPAN

• Japanese Ministry of Health, Labour and Welfare Guideline on Control of Computerized Systems in Drug Manufacturing

3.5 CANADA

• Canadian Health Products and Food Branch Inspectorate GMP Guidelines 2002 Edition Version 2
• Canadian Health Products and Food Branch Inspectorate Annex 2 to GMP Guidelines 2002 Edition Version 2 – ‘Manufacture of Drugs Used in Clinical Trials’
• SOR/98-282 – Medical Devices Regulations

3.6 CHINA

• Drug Administration Law of the Peoples Republic of China
• Regulations for Implementation of the Drug Administration Law of the Peoples Republic of China
• Regulations for Supervision and Administration of Medical Devices
• Regulations on Administrative Protection for Pharmaceuticals

3.7 INTERNATIONAL

• OECD ENV/MC/CHEM(98)17 ‘The Application of the Principles of GLP to Computerised Systems’ – issued 26/01/1998
• ICH E1 – The Extent of Population Exposure to Assess Clinical Safety
• ICH E10 – Choice of Control Group in Clinical Trials
• ICH E2A – Clinical Safety Data Management
• ICH E2B Q&A(R5) – (ver.1.1) March 2005
• ICH E2B(R3) – REVISION of the Clinical Safety Data Management
• ICH E2C(R1) – Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs
• ICH E2D – Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting
• ICH E2E – Pharmacovigilance Planning
• ICH E3 – Structure and Content of Clinical Study Reports
• ICH E4 – Dose-Response Information to Support Drug Registration
• ICH E5 Q&A(R1) – June 2006
• ICH E5(R1) – Ethnic Factors in the Acceptability of Foreign Clinical Data
• ICH E6(R1) – Guidelines for Good Clinical Practice
• ICH E7 – Studies in support of Special Populations: Geriatrics
• ICH E8 – General Considerations for Clinical Trials
• ICH E9 – Statistical Principles for Clinical Trials
• ICH E11 – Clinical Investigation of Medicinal Products in the Pediatric Population
• ICH E12A – Principles for Clinical Evaluation of New Antihypertensive Drugs
• ICH E14 – The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential
• ICH E15 – Terminology in Pharmacogenomics
• ICH M1 – MedDRA – Medical Terminology
• ICH M2(R2) – Electronic Transmission of Individual Case Safety Reports Message Specification
• ICH M3(R1) – Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals
• ICH M4(R3) – Organisation Of The Common Technical Document For The Registration Of Pharmaceuticals For Human Use
• ICH M4E(R1) – The Common Technical Document For The Registration Of Pharmaceuticals For Human Use: Efficacy
• ICH M4Q(R1) – The Common Technical Document For The Registration Of Pharmaceuticals For Human Use: Quality
• ICH M4S(R2) – The Common Technical Document For The Registration Of Pharmaceuticals For Human Use: Safety
• ICH M5 – Data Elements And Standards For Drug Dictionaries
• ICH Q1A(R2) – Stability Testing of New Drug Substances and Products
• ICH Q1B – Stability Testing : Photostability Testing of New Drug Substances and Products
• ICH Q1C – Stability Testing for New Dosage Forms
• ICH Q1D – Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
• ICH Q1E – Evaluation of Stability Data
• ICH Q1F – Stability Data Package for Registration Applications in Climatic Zones III and IV
• ICH Q2(R1) – Validation of Analytical Procedures: Text and Methodology
• ICH Q3A(R1) – impurities in new drug substances
• ICH Q3B(R2) – impurities in new drug products
• ICH Q3C(R3) – impurities: guideline for residual solvents
• ICH Q4 – Pharmacopoeias
• ICH Q4A – Pharmacopoeial Harmonisation
• ICH Q4B – Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
• ICH Q4B (Annex 1) – Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Residue on Ignition/Sulphated Ash General Chapter
• ICH Q5A(R1) – Viral Safety Evaluation Of BioTechnology Products Derived From Cell Lines Of Human Or Animal Origin
• ICH Q5B – Quality Of BioTechnical Products
• ICH Q5C – Stability testing Of BioTechnological/Biological Products
• ICH Q5D – Production Of BioTechnological/Biological Products
• ICH Q5E – Comparability Of BioTechnological/Biological Products Subject To Changes In Their Manufacturing Process
• ICH Q6A – test procedures and acceptance criteria for new drug substances and new drug products: chemical substances
• ICH Q6A (Decision Trees)
• ICH Q6B – test procedures and acceptance criteria for biotechnological/biological products
• ICH Q7 – Good Manufacturing Guide For Active Pharmaceutical Ingredients – 10 November 2000
• ICH Q8 – Pharmaceutical Development
• ICH Q9 – quality risk management
• ICH Q10 – Pharmaceutical Quality System
• ICH S1A – Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals
• ICH S1B – Testing for Carcinogenicity of Pharmaceuticals
• ICH S1C(R1) – Dose Selection for Carcinogenicity Studies of Pharmaceuticals
• ICH S2A – Genotoxicity: Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals
• ICH S2B – Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals
• ICH S3A – Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies
• ICH S3B – Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies
• ICH S4 – Duration of Chronic Toxicity Testing in Animals (Rodent and Non-Rodent)
• ICH S5(R2) – Detection of Toxicity to Reproduction for Medicinal Products
• ICH S6 – Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
• ICH S7A – Safety Pharmacology Studies for Human Pharmaceuticals
• ICH S7B – The Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization

TABLE OF CONTENTS

GLOSSARY

REFERENCES

REGULATORY STANDARDS