21 CFR 210 and 211
Current Good Manufacturing Practices (cGMP) in manufacturing, processing, packaging, and holding of drugs

210.1 Status of cGMP regulations

(a) Regulations in 210, 211, 226 is for drugs, 600-680 pertains to biological products for human use, Part 1271 is applicable to human cell, tissue, or other cellular or tissue based product that is a drug. These are considered supplement and do not supersede each other unless regulations explicitly provide otherwise. In event of conflict, regulations specific to product supersede general regulations.
(b) If engaged in operations such as (a), individual needs to only comply to applicable regulations.
(c) Investigational drug for use I phase 1 (312.21a) subject to 21 USC 351 (a)(2)(B) exempt from 21 CFR 211 unless available for use in phase 2 or 3.

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(a) There should be a quality control unit that has responsibility to approve or reject all components, review records, investigate errors, and approve or reject products at contract facility/company.
(b) There should be adequate lab facilities for testing and approval
(c) Quality control unit approves or rejects all procedures or specifications impacting the product.
(d) All responsibilities and procedures applicable to QC unit are in writing and followed

(a) All personnel must have adequate education or training for all applicable procedures including cGMP and regulations.
(b) Supervisors must have adequate education and training for all applicable procedures including cGMP and regulations that they supervise.
(c) There shall be an adequate number of personnel for operations; performing and supervising.

(a) Personnel must have clean clothing. Personnel shall wear protective apparel as necessary to protect product from contamination
(b) Personnel shall have good sanitation and health habits
(c) Limited access to areas with authorized personnel only
(d) Personnel shall not have illnesses or open lesions, any health conditions shall be reported

Consultants shall have education, training, or experience necessary as applicable. Name, address, qualifications, and type of service shall be recorded.

(a) Facility adequate size, construction, and location for proper cleaning, maintenance, and operations
(b) Adequate space for orderly placement of equipment and materials to prevent mixups and contamination. Flow is designed to prevent contamination.
(c) Operations performed in specifically designed areas of adequate size. Separate/defined/controlled areas for:
1. Receipt, identification, storage, withholding pending sample/test/or exam by QC for release
2. Rejects
3. Released component storage, Labelling
4. In-process storage
5. Manufacturing and process operations
6. Packaging and Labelling
7. Quarantine Storage
8. Product storage after release
9. Control and Lab operations
10. Aseptic processing
  - (i) floor, wall, and ceiling smooth and hard surface that is easily cleanable
  - (ii) Temperature and humidity controls
  - (iii) Air supply is HEPA, positive pressure
  - (iv) System for monitoring environmental conditions
  - (v) System for cleaning and disinfecting
  - (vi) System to maintain equipment used to control aseptic conditions
(d) Operations with penicillin are separate from other drugs for human use.

Adequate lighting for all areas