Pharmaceutical Regulations - Good Manufacturing Practice (GMP)

These flashcards cover key concepts and details about Good Manufacturing Practices (GMP) in pharmaceutical regulations.

What does GMP stand for?

Good Manufacturing Practice

What is GMP?

Policies and procedures for management of production steps, quality assurance, and post-production monitoring that minimizes the risk of delivering unsafe, outdated, contaminated, or low-quality pharmaceutical products to the patients.

Quality control

Tests and analyzes raw material, unfinished dosage forms

Quality assurance

Monitors all the planned and systematic activities applied within the quality system to provide adequate confidence that the predetermined standards for quality and safety will be met

What does quality assurance create?

SOPs

What are the most important elements in GMP?

People, Environment & Equipment, Procedures, and Quality Management.

Human resources

hiring qualified personnel with proper education and/or work experience

How do we ensure personnel qualification?

Through human resources, on-site training, and standard operating procedures.

On-site training

Every company does things differently, and therefore, even most qualified new hires need to be trained for specific protocols.

Personnel Management

Ensuring proper placement (right position to right personnel) motivation for growth (positive reinforcement, promotions, etc.), and providing mentors for further development

Standard Operating Procedures (SOPs)

Providing the validated SOPs ensures desired outcomes

Hygiene

Education; Providing proper accessories; Premises

Contamination

Presence of foreign particles/organisms in a product or compound

Cross-contamination

Presence of one product (or components of it) in another

Size and separation

Larger spaces and proper separation of manufacturing units prevent Cross-contamination

Sanitation

Validated SOPs for cleaning ensures prevention of both contamination and cross-contamination

Personnel and Material Traffic

Entering a manufacturing units might mean entering microorganisms and/or foreign particles. Also, personnel and material can bring with them particles from another product into this space. Limiting and controlling traffic can prevent both contamination and cross-contamination

Defined specifications

Positive air pressure in sterile spaces prevent contamination with microorganisms from outside. Negative air pressure prevents fine powder particles exiting the tableting unit. Therefore, specifications regarding the spaces prevent both contamination and cross- contamination

Labeling

Labeling all the material prevents using materials of one product in another, and therefore, minimizes the risk of cross-contamination

Batch

A specific quantity of a product that is intended to have uniform character and quality, within specific limits, and is produced according to a single manufacturing order during the same cycle of manufacture

Lot

A batch, or a specific identified portion of a batch, having uniform character and quality within specified limits; or, in the case of a drug product produced by continuous process, it is a specific identified amount produced in a unit of time or quantity in a manner that assures it would have uniform character and quality within specified limits

What's the difference between batch and lot?

Batch refers to a specific quantity of product while a lot is a subdivision of a batch

Validation

Extremely important for any SOP, so we can confirm that the recommended procedure would actually achieve the pre-defined goals. It is done under direct supervision of Quality Assurance

Types of Quality Control

Production Environment, Raw Material, Intermediate Control (In-process control), Finished Products, Stability

Is Active ingredient a raw material?

Yes

Is Lactose a raw material?

Yes

Is Water a raw material?

Yes

Is Aluminum Foil a raw material?

No

What do we need for quality control?

Sampling guidelines; Written procedures; Trained analysts; Calibrated equipment

Stability Testing for new drugs

Estimate shelf-life by accelerated testing

Stability Testing for existing products

Assuring the accuracy of shelf-life by periodic testing

What is stability testing?

Testing conducted to estimate shelf-life or assure the accuracy of shelf-life of drugs

Limit of Detection

the sensitivity of the equipment

Limit of Quantification

similar to the concept of minimum measurable quantity

What is larger limit of quantification or limit of detection?

limit of quantification

Robustness

insensitivity to details of the method used

Ruggedness

insensitivity to changes when the method is used in different labs