Quality Control and Testing of Pharmaceuticals

Leveraging Knowledge and Advanced Technology for Ensuring High-Quality Pharmaceuticals

Quality control (QC) is vital in pharmaceutical manufacturing.

QC laboratories are responsible for evaluating raw materials all the way to releasing the product in its final packaging.

They are essential in ensuring the safety, efficacy, and purity of the drugs administered to patients.

Reliable instruments and software are necessary to ensure the strict quality and safety standards the authorities require.

Quality Control and Testing of Pharmaceuticals

METTLER TOLEDO specializes in process analytics, advanced product inspection solutions, and services for pharmaceutical companies, and offers a wide range of laboratory instruments and weighing equipment that that, combined with laboratory software or industrial SQC software, ensure efficiency and compliance with FDA 21 CFR Part 11.

The Challenges of QC Laboratories

Quality control laboratories are crucial in meeting compliance and regulatory requirements in the pharmaceutical industry's highly regulated environment.

They must provide insurance across various therapeutics and drug delivery routes through reliable, traceable, and compliant results.

As the complexity and testing requirements of pharmaceutical manufacturing increase, QC laboratories face growing pressure to improve operational efficiency, better manage and allocate resources, and ensure they deliver real business value.

All of this must be done within a highly regulated operating environment with ongoing concerns about data integrity.

To ensure drug safety and comply with good manufacturing practices (GMP) standards, scientists perform analytical tests on raw materials, active pharmaceutical ingredients (APIs), and excipients following pharmacopeia guidelines to ensure no impurities or adulterants are identified above a threshold level.

There are commonly used in QC:

Conductivity and pH measurements,
Thermal analyses (melting point, differential scanning calorimetry (DSC), thermogravimetric analysis (TGA)),
UV-Vis spectroscopy,
Density and refractometry measurements,
Titration of specific molecules, or Karl Fisher titration for water content determination

Quality control of raw materials, API, and Final Drug Form

Synthesis, formulation and Quality Control of Small Molecules Drugs

Drug Product Inspection

For the pharmaceutical industry there are continuing efforts to adopt rising cost pressures, increased production complexity, and a faster time to market without compromising on quality and regulatory compliance.

Integrating advanced inspection technologies can help with these challenges to support an effective and compliant drug production process.

Weight-Based Statistical Quality Control

Weight-based statistical quality control software is used in pharmaceutical manufacturing to ensure that the weights of individual tablets or capsules meet the required specifications.

The software is designed to analyze the data collected during manufacturing and identify any variations or trends that could impact the quality of the final product.

The software uses statistical methods to establish control limits for the weight of each tablet or capsule, based on the expected weight and the acceptable range of variation.

During manufacturing, the software continuously monitors the weight of each tablet or capsule and alerts the operator if any weight falls outside the established control limits.

This helps manufacturers to identify and correct any issues with the manufacturing process quickly, before they impact the quality of the final product.

Additionally, weight-based statistical quality control software provides a record of the manufacturing process and the weights of each tablet or capsule produced, which can be used for documentation and regulatory purposes.

In pharmaceutical production, Quality Control (QC) and Analytical Service laboratories ensure product consistency, safety, and compliance but often face inefficiencies due to high demands.

Process Analytical Technology (PAT) offer real-time data, enhancing QC by reducing backlogs and supporting continuous manufacturing. PAT provides proactive process control, ensuring consistent monitoring of critical quality attributes and process parameters.

While not replacing traditional QC, PAT complements it by improving efficiency and effectiveness.

Strategic implementation of PAT tailored to specific production stages can alleviate pressures on QC labs, maintaining high-quality production that meets regulatory standards and consumer expectations.

With PAT, the process is well understood, leading to a predefined product quality that reduces regulatory concerns and increases process efficiency.

Quality is built into the process design and is not tested into the products.

METTLER TOLEDO solutions are an excellent fit to help you ensure the quality of the final active pharmaceutical ingredient (API) and biopharmaceutical.

Calibration, Qualification and Maintenance for Your Solutions

METTLER TOLEDO Service is your one-stop shop for all your balance service, scale service, and inspection device service needs. From installation and initial calibration to preventive maintenance and timely upgrades, we ensure your operations run smoothly and efficiently.

Achieve and maintain compliance through consistent procedures and adhere to local and global regulations and standards, such as:

ISO 17025

EURAMET

USP, GLP and GMP

NIST Handbook 44 and OIML

Measuring Instruments Directive (MID)

Ensure a perfect start and ongoing, worry-free use with immediate and long-term benefits:

Assurance that the equipment is fit for use

Cost-savings through manufacturer's qualification services

Confidence that the equipment meets process requirements

Identification of needed calibration and maintenance

Pre-plan your periodic maintenance that provides you with complete trust that your equipment achieves:

Consistent, accurate results

Safe and reliable operation

Optimal performance possible

A longer equipment lifespan, resulting in a higher ROI

Lab Pharmaceutical Quality Control Guide

This guide delves into the essential aspects of modern pharmaceutical compliance, focusing on crucial elements such as:
- data integrity,
- automation,
- process analytical technology (PAT),
- and the importance of service and training.

These components are vital in ensuring the accuracy, efficiency, and compliance of pharmaceutical operations.