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• Different to research laboratories or facilities, GMP facilities for cellular produc-
  tion are only investigated when some technologies that used in these facilities
  were located. All suggested equipment should be arranged according to the
  stages of the production line.


• IVD- and FDA-approved equipment or research only equipment: IVD- and
  FDA-approved equipment is considered as priority machines to purchase for a
  GMP facility. However, not all machines for cellular production are compliant
  with IVD or FDA conditions. Moreover, IVD- and FDA-approved equipment
  will have higher prices than non-IVD- and FDA-approved equipment. Therefore,
  IVD- and FDA-approved equipment should be used at certain steps of produc-
  tion, especially at quality control steps with measurement equipment.


• All equipment (IVD/ FDA approved or not) must be validated after installation
  and SOPs established for maintenance, calibration, and work instructions
  (Table 6.4 ).

6.4 Regulation of MSC Production

MSC production is regulated differently worldwide. Most regulations were established
in Europe and the USA. In recent years, some developed countries such as Japan and
Korea have also published regulations related to the production and usage of MSCs.

Table 6.4 Elements that should be carefully considered for cellular production in GMP facilities

No. Elements Specifi cs

1 Quality program Formal quality program, all aspects of operations,

assure GMP compliance

2 Organization and personnel Personnel qualifi cation, training

3 Procedures SOPs for all signifi cant manufacturing steps,

authorizations of deviations

4 Facilities Facility and equipment operations, cleaning,

validation

Equipment and environmental monitoring

5 Environmental control,

monitoring

6 Equipment

7 Supplies and reagents Requirements, qualifi cation, control of materials

8 Process controls Validation, control of manufacturing processes,

process modifi cations

Corrective action plan

9 Process changes

10 Process validation

11 Labeling controls Controlled product labeling, prevention of mix-ups

12 Storage Provisions for raw materials, product storage

13 Receipt and distribution Record keeping, data management

Tracking—from donor to recipient, recipient to donor

Outcome analysis, deviation tracking, AE reporting

14 Records

15 Tracking

16 Complaint fi le

P.V. Pham and N.B. Vu