cgmp chapt 3

purpose of cgmp regulation

to ensure drug identity, strength, quality and purity

CFR titles 210 and 211

part 210: general manufacturing, processing, packing or holding of drugs

part 211: finished pharmaceuticals

3 main sections of CFR part 210

210.1 minimum requirements for cgmp regulations

210.2 applicability of CGMP to drugs, biologics and HCT/Ps

210.3 definitions

CFR part 211 subparts

A: general provisions

B: organization and personnel

C: buildings and facilities maintenance and design

D : equipment maintenance and design

subpart A

minimum cgmp requirements for preparing drug products for humans and animals

subpart B

• QA

• QC

• personnel qualifications

• consultants

responsibility of QA

ensures processes and systems are in place to maintain product quality.

set and enforces quality standards throughout the production process

QC

verifies the quality of drug components, packaging, and finished products through testing and inspection

personnel qualifications

• appropriate: education, training and experience in CGMP requirements to ensure compliance

personnel responsibilities

• maintain personal hygiene and wear protective apparel

• ensure they are fit for duty

consultant requirements

• sourced from outside the company

• requires education, training and experience

building requirements

• prevent contamination

• include controls for microorganisms, temperature and humidity

• appropriate construction materials

environmental controls

• ventilation: HEPA filters, positive pressure

• control dust, microorganisms, temperature and humidity

plumbing

portable water under positive pressure

washing

hot/cold water, soap, air dryers, or single-use towels

aseptic processing

• HEPA-filtered air under positive pressure

• regular environmental monitoring

sanitation

• building must be clean and pest-free

• waste must be disposed of safely and promptly

contamination prevention

• dedicated storage for quarantined, rejected and approved materials

• to minimize risks of cross-contamination

maintenance

• regular inspections and repairs

• address structural or pest issues immediately

construction materials (walls, floor, ceilings)

walls: smooth and durable

floors: chemical-resistant, cleanable

ceilings: seamless and designed to prevent dust accumulation

requirements for equipment design

• appropriate for intended use

• easy cleaning and maintenance

• prevent contamination

equipment construction materials

• prevent contact between products and substances like lubricants or coolants

• ensure all parts in contact with drugs are non-reactive and safe

cleaning and maintenance

• cleaned and sanitized at appropriate intervals

• follow validated written procedures for cleaning

• keep records of cleaning and maintenance activities

validation of cleaning

• ensures the cleaning process consistently meets specifications

• prevent residue buildup and cross-contamination

what are the requirements for automated equipment?

changes in records must be authorized by qualified personnel

maintain hard copy backups or alternative systems like tapes or microfilm

maintenance records

• records of all cleaning, reports and maintenance

• documentation ensures accountability and traceability

filters

• filters must not release particles or substances into products

• must be regularly inspected and maintained

overall equipment goals

ensure all equipment is safe, clean and functional