Current Good Manufacturing Practices

A set of minimum requirements established by regulatory authorities to ensure that medicines are consistently produced and controlled according to quality standards

Good manufacturing practices (GMP)

The updated and evolving form of GMP — the "c" stands for

current

Why cGMP Matters for patients

1. product safety/quality

2. consistency

Why cGMP Matters for manufacturer

1. Facilitates Regulatory Compliance

2. Improves Operational Efficiency

3. Enhances Market Readiness

4. Minimizes Risk and Mistakes

When cGMP fails, it's not just a company problem — it's a ________________

patient safety problem

Consequences of Failed cGMP

1. harm

2. recalls

3. regulatory action

4. financial

5. public trust

Enforces/regulates cGMP through 21 CFR Parts 210 & 211 (for drugs) and other parts for biologics, medical devices, dietary supplements.

U.S. FDA (Food and Drug Administration)

Key Aspects of GMP Regulation

1. product focus

2. core principles

3. enforcement

4. legal authority

Foundational Principles of cGMP (5 P's)

1. people

2. product

3.premises

4. processes

5. procedure

Qualified, trained, and responsible staff. • Follow SOPs and maintain hygiene.

people

Final outcome of all the above. • Must be safe, effective, and consistent in quality

product

Documentation of everything • SOPs, batch records, deviations.

procedure

Standardized, validated manufacturing methods. • Ensure reproducibility and control.

processes

Properly designed, maintained, and clean facilities. • Prevents cross contamination and errors.

premises

Written, detailed instructions that describe how to perform specific tasks consistently.

SOPs

purpose of SOPs is to ensure _________________________ with GMP

reliability, standardization, and compliance

examples of SOPs

1. Procedures for cleaning equipment

2. sampling raw materials

3. labeling

4. handling deviations

5. conducting stability testing.

importance of SOPs

1. Prevents errors

2. ensures training consistency

3. provides traceability for audits and inspections

A system-oriented function that ensures the entire manufacturing process consistently produces products that meet quality standards

Quality Assurance (QA)

role of Quality Assurance (QA) is preventive — focuses on building __________ into the process

quality

responsibilities of Quality Assurance (QA)

1. Approving SOPs and batch records

2. Overseeing training and compliance

3. Reviewing deviations and approving corrective actions

4. Final authority on batch release

A product-oriented function that tests and verifies materials and products

Quality Control (QC)

role of Quality Control (QC) Detective — focuses on ____________ defects

identifying

responsibilities of quality control (QC)

1. Sampling and testing raw materials, in-process samples, and finished products

2. Stability testing and environmental monitoring.

3. Ensuring results meet established specifications before release

Documented evidence that a process, method, or equipment consistently produces results meeting predefined criteria

validation

types of validation

1. process

2. method

3. equipment/computer system

Ensures manufacturing processes deliver consistent product quality

process validation

Confirms analytical methods are reliable and accurate.

method validation

Ensures machines/software function as intended

Equipment/Computer System Validation

Currently GMP guidelines (required in the pharmaceutical industry) are not _________________ in pharmaceutical compounding activities.

mandatory

Community pharmacists must ___________ with state board of pharmacy regulations and guidelines to assure quality product.

comply

preparation, mixing, assembling, packaging and labeling of drug products based on a Rx from a licensed practitioner for an individual Pt.

extemporaneous prescription compounding