Week 11 (cGMP)

What are good manufacturing practices (GMP)?

minimum legal requirements for manufacturing of drugs

Describe the branching of the Code of Federal Regulations (CFR) into cGMPs?

CFR → Title 21 Food and Drugs → Drugs (200 series), Biologics (600 series), Medical Devices (800 series) → each series will have its cGMPs

What are the 3 standards that must be maintained for drugs and biologics?

drugs: safe, pure, effective

biologics: safe, pure, potent

What does SQUIPP stand for

safety, quality, identity, purity, potency

What are some examples of actions that can lead to citations?

QC of thermometer/scale not performed, failure to report errors to FDA, incomplete maintenance records

What should effective documentation provide?

trackability and traceability

What are the do’s and don’ts for documentation?

Do’s: document concurrently, legible writing, blue or black ink only, concise, review before handoff

don’ts: document after, ineligible, other colors, handing off documents before reviewing

What does personnel qualification 21 CFR Part 211.25 state?

every person must have education, training, and experience to manufacture a product

What does personnel responsibilities 21 CFR 211.28 state?

must have PPE and demonstrate knowledge and application of SOPs and new skills

What is error management?

a process or system that can identify errors

What is form 483?

a list things that need to be corrected after an FDA inspection

What are SOPs?

standard operating procedures: a live document providing instruction on how to perform a task

What does it mean by SOP’s having to be current and controlled?

current: if a process changes, SOP must be revised 1st

controlled: all copies must be current with revision dates and edition numbers

What does production and process control 21 CFR 211.100 state?

there shall be written procedures for production and process control to assure products have identity, strength, quality, purity

What does lab controls 21 CFR 606.140 state?

standards and test procedures ensure blood products are safe

What does compatibility testing 21 CFR 606.151 state?

positive ID of recipient samples and crossmatching procedure

What must proper labeling have?

name of component, name/address of manufacture, expiration date, volume of component, storage temp