Unit 1: pharmaceutical Quality and cGMPs

Code of Federal Regulation

List of laws and regulations by the executive branch

Title 21/ 21 CFR

includes food and drug regulations, and expectations for bio manufacturers

cGMP

set of standards by FDA to ensure safety and purity of drug products

Efficacy

refers to whether a drug demonstrates a health benefit over interventions during clincial tiral

Quality

product is both safe and effective

Three types of FDA Inspections

General cGMP Inspection, Pre-approval Inspections (PAI), for-cause audits

Deviation

anything that is not following SOP

What departments consist of quality units?

QA, QC, Quality Systems, Training

Quality Assurance (QA)

Oversees overall site quality, including reviewing batch records, and observe operations on the production floor

Quality Control (QC)

labs, verify products if they are free of contamination

Quality Unit is responsible for

performing internal audits of company operations to ensure everything is in compliance before FDA external audit.

ALCOA+

Attributable, legible, contemporaneous, original, accurate

Data integrity

completeness, consistency, and accuracy of data over its lifecycle

Validation

Confirming that processes are consistent to predetermined specifications

Qualification

testing equipment to prove they work they way it was designed to work

Equipment must be _______ and ________ before being used in biopharmaceutical production

validated and qualified

Calibration

process to ensure the accuracy of instruments

Preventative Maintenance

prevent things from happening

corrective maintenance

activities performed in response to damages

Forward traceability

starts with one material and trace it to every process it’s being used

Backwards traceability

take a process batch and know every single material that went into it

Line Clearance

ensuring all materials from previous batch is removed from production area to prevent cross contamination