Framework for continuous improvement - Quality Assurance - page 6

Of course, the use of SOPs in manufacturing in the life
sciences industry is also a regulatory requirement. FDA
has stipulated, “There shall be written procedures for
production and process control designed to assure that the
drug products have the SISPQ they purport or are represented
to possess.” Furthermore, “such written procedures shall
be followed.” 5 FDA has stated similar predicate rules for
written SOPs for many of the areas under its jurisdiction, as
displayed in Table 1.1. FDA has even stipulated predicate
rules for written SOPs that apply to itself, Good Guidance
Practices . 6
What are some of the consequences of the absence of
written procedures?

■ Without SOPs there is confusion about what the task is
and where the task should be performed.
■ Without an SOP the task performance will be poorly
resourced - either under-resourced or wastefully resourced.
In either case, task performance is more costly, since the

Table 1.1

FDA predicate rules for written SOPs

Regulated Area Regulation Predicate Rule

￿ ￿ ￿ ￿ ￿

Biologics 21 CFR 600.80 Post-market AEs

Food 21 CFR 179.25 Food irradiation

GCP 21 CFR 56.101 IRBs

GCP 21 CFR 310.305;

§314.80

Post-market AEs

GLP 21 CFR 58.35 QA unit

GMP 21 CFR 211.186 Control records

GTP 21 CFR 1270.31;

§1271.180

Good tissue practices

HAACP 21 CFR 120.11 Calibration

Medical Devices 21 CFR 812.25 Investigational plan