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`AstraZeneca Exhibit 2022
`Lannett v. AstraZeneca
`IPR2015-01629
`
`

`
`NOTICE AND WARNING
`
`Concerning U.S. Patent or Trademark Rights
`
`The inclusion in the Pharmacopeia or in the National Formulary of a monograph on any drug in
`respect to which patent or trademark rights may exist shall not be deemed, and is not intended
`as, a grant of, or authority to exercise, any right or privilege protected by such patent or
`trademark. All such rights and privileges are vested in the patent or trademark owner, and no
`other person may exercise the same without express permission, authority, or license secured
`from such patent or trademark owner.
`
`Concerning Use of USP or NF Text
`Attention is called to the fact that USP and NF text is fully copyrighted. Authors and others
`wishing to use portions of the text should request pennission to do so from the Secretary of the
`USPC Board of Trustees.
`
`The United States Pharmacopeial Convention, Inc.
`© 1999
`12601 Twinbrook Parkway, Rockville, MD 20852.
`All rights reserved
`ISSN 0195-7996
`ISBN 1-889788-03-1
`
`Printed by National Publishing, Philadelphia, PA
`
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`

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`USP 24
`
`General Information / (1078) Good Manufacturing Practices
`
`2047
`
`Nonconforming Material: any material that does not meet manu~
`facturer’s
`specifications or
`applicable good manufacturing
`practices.
`
`Packaging:
`product.
`
`the act of filling and labeling a container with a
`
`Packaging Material: the containers, closures, and labels employed
`in the packaging of a product.
`Processing Instructions: the manufacturing procedures set forth in
`the master formula.
`
`Commingling: the blending of trace carryover material from one
`grade of an excipient with another, usually due to a continuous
`process.
`
`Contaminant: an impurity not intended to be present in an excip-
`ient, which may be introduced by poor cleaning, processing, or
`lack of appropriate environmental and personnel controls during
`the manufacturing process.
`Continuous Process: :1 manufacturing process that continually pro-
`duces an excipient from a continuous supply of raw materials.
`Critical Process: 21 manufacturing process step that may cause vari-
`ation in quality attributes.
`Cross-contamination: contamination during production of a raw
`material, intermediate, or of a finished excipient with another raw
`material, intermediate, or product.
`DMF: detailed information submitted to the United States Food and
`Drug Administration concerning a specific facility, process, or prod-
`uct intended for incorporation by reference into a new drug appli-
`cation, supplemental new drug application, abbreviated new drug
`application, or investigational new drug application.
`Excipient: any substances, other than the active drug or product,
`that have been appropriately evaluated for safety and are included
`in a drug delivery system to either aid the processing of the drug
`delivery system during its manufacture, protect, support or en-
`hance stability, bioavailability, or patient acceptability, assist in
`product identification, or enhance any other attribute of the over-
`all safety and effectiveness of the drug delivery system during
`storage or use.
`
`Expiration Date: the date beyond which the product may no longer
`conform to relevant specifications.
`Finished Dosage Form (Drug product): a finished pharmaceutical
`product, prepared for consumer applications, containing excipi-
`ents and the active drug substance.
`
`Finished Product: any pharmaceutical product that has undergone
`all stages of production, including packaging and labeling,
`Finished Process Materials: any material that has undergone all
`stages of production and is released from quality control.
`Homogeneous Material: throughout the batch, material of uniform
`consistency and composition.
`Impurity: a substance contained in a product other than the desired
`substance.
`
`In-Process Testing: monitoring checks performed during produc-
`tion to ensure that the product conforms to its specifications.
`In-Process Material: any material that must undergo further man-
`ufacture before it becomes a bulk product.
`Intermediate Product: any material
`that must undergo further
`manufacturing steps before it becomes a bulk product.
`Lot: See Batcl .
`
`the company that performs the final production
`Manufacturer:
`steps and release of the product,
`Manufacturing Process: all steps necessary to produce a finished
`product from raw materials.
`
`Master Formula (Master Formula Record): documentation de-
`scribing the manufacture of the excipient from raw material to
`completion of the lot or batch.
`
`Material Review Board: a committee or group selected to evaluate
`the disposition of potentially nonconforming material.
`Model Product: 21 product that simulates a group of like products.
`Mother Liquor: a concentrated solution from which the product is
`obtained by evaporation, freezing, or crystallization.
`Re-evaluation Date: that date beyond which the bulk pharmaceu-
`tical excipient should not be used without prior adequate re-
`examination.
`
`Representative Sample: a sample drawn according to an appro-
`priate sampling plan, which may involve regular or random
`selection.
`
`introducing back into the process previously pro-
`Reprocessing:
`cessed material that did not conform to standards or specifications
`and repeating steps that are already part of the normal manufac-
`turing process.
`
`Production: all operations involved in the preparation of an excip-
`ient pharmaceutical product,
`from receipt of raw materials
`through the completion of a finished product.
`Purification: the process of removing impurities from a substance.
`Quality: the totality of features and characteristics of a product that
`bear on its ability to satisfy stated or implied needs.
`Quality Assurance: all those planned and systematic actions nec-
`essary to provide confidence that a product or a service will sat-
`isfy given requirements for quality.
`Quality Control: all activities such as measuring, examining, test-
`ing, or gauging one or more characteristics of a product (includ-
`ing raw materials) and comparing the findings with specified re-
`quirements to determine conformity.
`Quality Control Instruments: Ineasurement instruments used to
`monitor the manufacturing process, in-process controls, and the
`finished excipient products for final quality control approval.
`Quarantine: the status of any material isolated physically or by
`other effective means while awaiting a decision on its use.
`Raw Material: any substance used in the production of a product
`excluding packaging materials.
`Reserve (Retained) Sample: a representative sample of the final
`excipient batch of sufficient quality and quantity necessary to
`perform quality control analyses twice.
`Returned Products:
`finished
`products
`manufacturer.
`
`to
`
`the
`
`sent
`
`back
`
`Reworking: introducing previously processed material that did not
`conform to standards or specifications to processing steps that are
`different from the normal process.
`Significant Processing Step: processing steps that are required to
`produce an excipient
`that meets the established physical and
`chemical criteria.
`
`Shelf life: the length of time during which the excipient exhibits
`stability.
`
`Specifications: the quality parameters that serve as a basis for qual-
`ity evaluation and to which the products or materials must
`conform.
`
`the continued conformance of the excipient
`Stability:
`specifications.
`Standard Operating Procedures (SOPS): a written authorized
`procedure that gives instructions for performing operations.
`Validation: documentation that states that any procedure, process,
`equipment, material, or activity consistently leads to the expected
`results.
`
`to its
`
`Vendor: an organization contracted to supply a material or perform
`a service.
`
`APPENDIX 2. GENERAL AUDITING CONSIDERATIONS
`
`Evaluation
`
`Prevention of Contamination——ln evaluating the adequacy of
`measures taken to prevent contamination of materials in the process,
`it is appropriate to consider the following factors:
`- Type of system (eg, open or closed. Closed systems in chem-
`ical plants are often not closed when they are being charged or
`when the final product is being emptied. Also, the same reac-
`tion vcssels are sometimes used for different reactions)
`' Form of the material (e.g., wet or dry)
`- Stage of processing and use of the equipment and/or area (eg.,
`multi-purpose or dedicated)
`- Continuous versus (discrete) batch production
`Other factors that should be considered in evaluating an excipient
`plant are the degree of exposure of the material to adverse environ-
`
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