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| Regulation, Specification, or Guidance
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Requirement
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21 CFR Part 211.103
21 CFR Part 226.40 (d)
WHO Technical Report Series, #986, Annex 2, 16.4 and 16.20
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17.1 The system should be able to calculate and record theoretical and actual percentage of yield at various phases of processing, manufacturing, and packaging.
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| 21 CFR Part 211.103
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17.2 The system should provide a means for verification and approval of yield calculations before release for reporting.
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21 CFR Part 820.20
21 CFR Part 820.40
21 CFR Part 820.186
E.U. Commission Directive 2003/94/EC Article 11
WHO Technical Report Series, #986, Annex 2, 1.0
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17.3 The system shall be able to maintain a production facility's quality system in a specific quality system record, in accordance with regulations and guidance such as 21 CFR Part 820.20 and 820.40 (U.S.), E.U. Commission Directive 2003/94/EC Article 11 (E.U.), and WHO Technical Report Series, #986, Annex 2, 1.0 (global).
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21 CFR Part 820.30
21 CFR Part 820.120 (e)
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17.4 The system shall be able to create a design control document capable of recording the details surrounding device development, including control number, physical and performance requirements, final output, review, verification, approval, transfer, changes, and complete design history.
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21 CFR Part 820.181
21 CFR Part 820.184
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17.5 The system shall be able to create a device master and device history record capable of recording all information described in 21 CFR Part 820.181 and 820.184.
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21 CFR Part 211.105 (b)
21 CFR Part 211.130 (e)
21 CFR Part 211.134 (c)
21 CFR Part 211.188
21 CFR Part 211.20 (d)
21 CFR Part 211.50 (c)
21 CFR Part 225.102
21 CFR Part 225.202
21 CFR Part 226.80
21 CFR Part 226.102
21 CFR Part 820.60
21 CFR Part 820.70 (a)
21 CFR Part 820.80 (c)
21 CFR Part 820.120 (d)
E.U. Commission Directive 2003/94/EC Article 9.1
FDA Hazard Analysis Critical Control Point Principle 2 and 4
FDA Hazard Analysis Critical Control Point Principle 7
WHO Technical Report Series, #986, Annex 2, 2.1 (a) and (f–g)
WHO Technical Report Series, #986, Annex 2, 15.25–30
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17.6 The system shall be able to create a batch production record capable of recording complete information regarding batch production and control details such as, but not limited to, a unique batch, lot, or production run number; formulation; specific labeling and packaging; production steps; in-process and laboratory control results; the unique identifier of any equipment used; persons performing and/or supervising operational steps; and the results of any pre-process or post-production inspections.
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21 CFR Part 211.186
21 CFR Part 212.50 (b)
21 CFR Part 225.102
21 CFR Part 226.102
FDA Hazard Analysis Critical Control Point Principle 7
WHO Technical Report Series, #986, Annex 2, 15.22–23
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17.7 The system shall be able to create a master production and control record capable of recording complete information regarding master production and control details.
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21 CFR Part 211.100
21 CFR Part 211.186
21 CFR Part 212.50 (b)
E.U. Commission Directive 2003/94/EC Article 10.3–4
WHO Technical Report Series, #986, Annex 2, 2.1 (a–b)
WHO Technical Report Series, #986, Annex 2, 4.0
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17.8 The system shall require a new or modified master production and control record to be validated, reviewed, and approved before being implemented into production, including allowing that record to be electronically signed by one or more authorized individuals upon approval. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.
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21 CFR Part 211.22
21 CFR Part 211.192
21 CFR Part 820.70 (b)
21 CFR Part 820.75
E.U. Commission Directive 2003/94/EC Article 10.3
WHO Technical Report Series, #986, Annex 2, 2.1 (a–b, f)
WHO Technical Report Series, #986, Annex 2, 4.0
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17.9 The system shall require a new or modified production and control record to be validated, reviewed, and approved before being implemented in production. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity.
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21 CFR Part 211.110
21 CFR Part 212.50
21 CFR Part 820.80 (c)
FDA Hazard Analysis Critical Control Point Principle 4
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17.10 The system shall be able to indicate if a sample consists of an in-process manufacturing material and track characteristics of the in-process material such as identity, strength, quality, purity, and approval status.
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| 21 CFR Part 211.111
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17.11 The system shall provide a means to track the amount of time between production processes.
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21 CFR Part 211.122 (c)
21 CFR Part 211.184
21 CFR Part 212.20 (b)
21 CFR Part 212.40 (c) and (e)
21 CFR Part 225.42
21 CFR Part 226.40 (b)
21 CFR Part 226.42
21 CFR Part 606.120 (b)
21 CFR Part 820.60
21 CFR Part 820.80 (b)
21 CFR Part 820.120 (b)
WHO Technical Report Series, #986, Annex 2, 14.4, 14.15, and 14.21
WHO Technical Report Series, #986, Annex 2, 15.32–33
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17.12 The system shall be capable of documenting the receipt of non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, medical devices, labeling, and packaging materials), including information such as manufacturer, date of receipt, lot numbers, reference numbers, certificates of conformity, shelf life or expiration date, storage location, status of examination, and status of approval for use. Any related specifications for those materials should be able to be linked to the received materials.
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21 CFR Part 211.122 (e)
21 CFR Part 211.125 (d)
21 CFR Part 211.184
21 CFR Part 225.42
21 CFR Part 226.42
WHO Technical Report Series, #986, Annex 2, 14.7 and 14.22
WHO Technical Report Series, #986, Annex 2, 16.35
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17.13 The system shall be capable of recording the changing quantity of inventoried non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, labelling, containers, and packaging materials), including batch and lot numbers and, if applicable, details of disposition after completion of production.
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21 CFR Part 211.122 (e)
21 CFR Part 211.125 (d)
21 CFR Part 211.184
21 CFR Part 225.42
21 CFR Part 226.42
21 CFR Part 606.100 (c)
21 CFR Part 820.80 (d–e)
21 CFR Part 820.90
21 CFR Part 820.160
WHO Technical Report Series, #986, Annex 2, 2.1 (g)
WHO Technical Report Series, #986, Annex 2, 14.4, 14.26, and 14.28
WHO Technical Report Series, #986, Annex 2, 15.44–45
WHO Technical Report Series, #986, Annex 2, 16.36
WHO Technical Report Series, #986, Annex 2, 17.18–19
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17.14 The system shall prevent the internal release for distribution of a completed production batch until an authorized individual has determined the batch's conformance to final specifications and has approved it for release. If a batch is nonconforming, the system shall be able to clearly document it as such (so as to not distribute it) and provide a review and disposition process. Such approval, rejection, review, and disposition activities shall be documented.
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21 CFR Part 7 Subpart C
21 CFR Part 211.192
21 CFR Part 810 Subpart B
E.U. Commission Directive 2003/94/EC Article 13
WHO Technical Report Series, #986, Annex 2, 6.0
WHO Technical Report Series, #986, Annex 2, 14.32
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17.15 The system shall provide a means to track and record recall activities of manufactured product and devices based on lot, batch, or other identifier, including storage location, necessary disposition details, and reconciliation between distributed and recovered quantities.
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21 CFR Part 211.165 (f)
21 CFR Part 211.204
21 CFR Part 212.71 (d)
21 CFR Part 820.90 (b-2)
WHO Technical Report Series, #986, Annex 2, 14.29–30
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17.16 The system should allow a completed production batch that has been rejected for use or a returned production batch to be flagged in the system for reprocessing or reworking if it meets relevant criteria.
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