QA/QC Requirements for Biotech Companies and the Benefits of a LIMS

QA/QC Requirements for Biotech Companies and the Benefits of a LIMS

The life sciences and biotechnology fields harness biological processes and organisms to create products that improve our lives. The most common biotech products are pharmaceuticals, diagnostic tools, agricultural products, industrial enzymes, and biofuels. Because these innovations directly affect our health, having rigorous quality control (QC) and quality assurance (QA) systems is essential. According to Vision Research Reports, the biotech market is expected to be worth $3.4 trillion by 2030. Therefore, QA/QC must be strictly applied in companies, regardless of whether they are start-ups or established enterprises.

Biotech firms have their work cut out for them. They need to meet stringent safety regulations while also figuring out how to cut costs without sacrificing quality or putting customers at risk. This is where quality management systems (QMS) and laboratory information management systems (LIMS) come into play. These systems help biotech companies navigate these challenges effectively.

What are QA and QC?

QA and QC are often used interchangeably, but they are different processes that take place at different times and are the responsibility of separate teams or employees. QA is a proactive process that identifies problems in advance of product development, while QC is a list of inspections/audits during the various stages of product development. Both work in sync to ensure that product quality meets the highest standards.

QA determines the systems and methods used to ensure product quality. One of the critical factors for robust QA is setting up standard operating procedures (SOPs). Product development and manufacturing is a collaborative effort involving multiple scientists. To ensure that the product quality is consistent, SOPs are a must for biotech companies. They should be written in an understandable and authoritative voice. SOPs must be clear and easy to follow and be able to accommodate minor changes in instrumentation. SOPs in product development are necessary for the following reasons:

• Maintaining consistency in the product development process each time a new product is manufactured  
• Ensuring that procedures or processes are carried out correctly and comply with regulations
• Training new employees in the correct methods of task execution and product development
• Reducing manual errors by enabling the employees to complete all tasks within the designed framework

The inspection phase of quality assurance is known as quality control. This is a sequence of tests performed to confirm a product's safety and effectiveness after it has been produced in large quantities. Both QA and QC are required. QC is responsible for testing or sampling to ensure compliance with the specifications set by QA. QC personnel take samples and test the products in several steps during production to ensure that all specifications are met.

Regulatory authorities, lawyers, patent offices, and peer-reviewed publications require the appropriate documentation to validate the product’s manufacturing process. Therefore, all departments are responsible for QA, as documentation is essential from the idea through product development to handover to the customer. In contrast, comparatively few QC employees are responsible for checking the quality of the product.

See our in-depth article on How a LIMS Helps Labs with QA and QC to learn more.

Key QA and QC Regulations for Biotech Companies

Some of the most commonly followed FDA and ISO QA/QC regulations in biotech companies are as follows:

• FDA Title 21 CFR 11: Electronic records; electronic signatures 
• FDA Title 21 CFR 201: Labeling 
• FDA Title 21 CFR 610: General biological product standards 
• FDA Title 21 CFR 1271: Human cells, tissues, cellular and tissue-based products
• ISO 9000: Quality management in the areas of product design, manufacturing, sales, and service
• ISO 15378: Standard for pharmaceutical primary packaging
• ISO 17025: Requirements for the competence, impartiality, and uniform working methods of laboratories 

Steps Towards QA in Biotech Companies

These are the steps that must be followed by biotech companies for their product and process development:

• Documentation: For consistent, high-quality outcomes, biotech companies must have well-defined processes for the product life cycle that are documented by all the departments.
• Training: Companies invest heavily in training and skill development to ensure teams are competent in implementing QA robustly.
• Audit: Periodic audits are conducted to ensure adherence to QA standards and continuous improvement for the teams and to meet the benchmarks for the expected quality level.
• Investigations: To reduce errors and defects in the final product, QA teams identify and mitigate potential risks by performing investigations at various stages of product development.
• Chain of Custody: QA focuses on the chain of custody for the approval of biotech products by maintaining a comprehensive record of sample ownership from collection through delivery, receipt, storage, analysis, and disposal.

Steps Towards QC in Biotech Companies

The following quality control steps are required to ensure that the products are properly tested for quality:

• Batch Inspection: This involves evaluating a representative sample from a batch to ensure consistency, quality, and compliance of the entire batch with predefined standards. This process is performed mostly before the batch release and after the product development.
• Product Sampling: A random sampling of products evaluates individual products regardless of the batch to detect defects and take corrective measures. This process is conducted at various stages, including during production, after production, and before shipping. 
• Validation Testing: Validation ensures that the products meet the customer's requirements and expectations. For example, in pharmaceutical industries, validation testing of the drug means that the drug is safe, effective, and consistent in its quality.
• Laboratory Testing: This involves a series of analytical and experimental tests to identify the purity, potency, safety, and efficacy of the products. The most common tests are for pH, viscosity, osmolality, the absence of endotoxins, mycoplasma, and bacterial and fungal contaminants.

As your laboratory expands, manually managing QA and QC using spreadsheets or written documents/lab notebooks becomes increasingly inefficient. Fortunately, cloud-based software platforms such as LIMS allow your laboratory to efficiently manage data and automate tasks, streamlining workflows and minimizing errors. A LIMS contributes to regulatory compliance and proper documentation, reinforcing the principle: “What is not documented is not done.” 

Should Labs Use a LIMS, QMS, or Both?

To support regulatory compliance for QA and QC, many labs still use a QMS. This is a logical choice, as a QMS (similar to a LIMS) is a software platform that assists laboratories to organize and standardize processes, procedures, and policies. A LIMS and a QMS should be viewed as “parts of the whole,” not as substitutes for each other. A QMS mainly helps with QA/QC  compliance.

Key areas that a QMS can help with QA/QC are:

• Document control
• Calibration of instruments
• Tracking of processes and modifications
• Supporting labs in meeting regulatory requirements (e.g., ISO 17025, 21 CFR 11)
• Ensuring that labs comply with Good Manufacturing Practice (GMP)

A LIMS serves a broader range of use cases than a QMS, providing sample management, inventory management, workflow automation features, billing management, analytics, and many other features to help a lab operate efficiently. Many labs use both a LIMS and a QMS to meet these needs, which increases expenses and requires IT expertise to integrate the two systems. We therefore recommend choosing a LIMS with a tightly integrated QMS. This reduces IT overhead by eliminating the need for two separate software systems for QA/QC. QBench for Life Sciences provides everything you need in one platform.

How LIMS Supports Biotech Companies With QA and QC

A LIMS can help your biotech lab in the following ways to comply with QA/QC:

Documentation

A LIMS can help with the proper documentation of the entire product life cycle, from ideation and discovery to delivery to the customer. It enables documentation by all departments: The engineering department can document the proper installation and operation of equipment. The regulatory affairs department can ensure compliance. The shipping department can track the receipt of raw materials and supplies and the packaging of products for the customer. And the R&D department can document the manufacturing process.

Labeling 

QBench is highly customizable and can be used to label instruments, raw materials, products, or other items in accordance with FDA regulation 21 CFR 201.

Chain of Custody

A well-defined chain of custody is crucial for the approval of biotech products. A LIMS, with its sample management and traceability features, helps to maintain a complete record of sample ownership from collection through delivery, receipt, storage, analysis, and disposal. This establishes the chain of custody, which is essential as evidence in legal proceedings concerning test or analysis results.

Electronic Records

QBench helps labs meet the requirements for the FDA Title 21 CFR Part 11 by maintaining accessible and accurate digital records. It features robust audit trails, enforces protocols with step sequencing and locks, provides configurable authentication options, and securely verifies signer identity with electronic signatures. 

Monitoring And Controls of Lab Equipment

A LIMS can be essential to maintaining quality control by monitoring and calibrating the instruments in your laboratory. This guarantees that all equipment is maintained and calibrated in accordance with established protocols, improving the accuracy and reliability of test results. 

21 CFR 1271

QBench helps biotech companies working with human cells, tissues, and cellular and tissue-based products (HCT/Ps) comply with FDA regulation 21 CFR 1271. It automates and streamlines the process of maintaining accurate inventory records in a timely manner. It also manages donor eligibility information, including screening and testing data, supporting good tissue practices as part of good manufacturing practices. QBench complies with FDA regulation 21 CFR 201 and ensures comprehensive labeling of HCT/Ps.

Quality Risk Management

A LIMS is crucial to mitigating the risks associated with product development. Centralized data management allows your team to access a product's data throughout its lifecycle and helps identify potential risks. It also allows your team to monitor SOPs followed throughout the manufacturing process and identify potential risks.

How LIMS Supports Biotech Companies With QA and QC

A LIMS can help your biotech lab in the following ways to comply with QA/QC:

Documentation

A LIMS can help with the proper documentation of the entire product life cycle, from ideation and discovery to delivery to the customer. It enables documentation by all departments: The engineering department can document the proper installation and operation of equipment. The regulatory affairs department can ensure compliance. The shipping department can track the receipt of raw materials and supplies and the packaging of products for the customer. And the R&D department can document the manufacturing process.

Labeling 

QBench is highly customizable and can be used to label instruments, raw materials, products, or other items in accordance with FDA regulation 21 CFR 201.

Chain of Custody

A well-defined chain of custody is crucial for the approval of biotech products. A LIMS, with its sample management and traceability features, helps to maintain a complete record of sample ownership from collection through delivery, receipt, storage, analysis, and disposal. This establishes the chain of custody, which is essential as evidence in legal proceedings concerning test or analysis results.

Electronic Records

QBench helps labs meet the requirements for the FDA Title 21 CFR Part 11 by maintaining accessible and accurate digital records. It features robust audit trails, enforces protocols with step sequencing and locks, provides configurable authentication options, and securely verifies signer identity with electronic signatures. 

Monitoring And Controls of Lab Equipment

A LIMS can be essential to maintaining quality control by monitoring and calibrating the instruments in your laboratory. This guarantees that all equipment is maintained and calibrated in accordance with established protocols, improving the accuracy and reliability of test results. 

21 CFR 1271

QBench helps biotech companies working with human cells, tissues, and cellular and tissue-based products (HCT/Ps) comply with FDA regulation 21 CFR 1271. It automates and streamlines the process of maintaining accurate inventory records in a timely manner. It also manages donor eligibility information, including screening and testing data, supporting good tissue practices as part of good manufacturing practices. QBench complies with FDA regulation 21 CFR 201 and ensures comprehensive labeling of HCT/Ps.

Quality Risk Management

A LIMS is crucial to mitigating the risks associated with product development. Centralized data management allows your team to access a product's data throughout its lifecycle and helps identify potential risks. It also allows your team to monitor SOPs followed throughout the manufacturing process and identify potential risks.

Need help understanding how to meet QA and QC regulations?

Do you want to ensure compliance with QA and QC regulations? Get in touch to get expert advice from our expert team of former laboratory staff. They can can also give a demo to show you how our combined LIMS + QMS makes compliance much faster and your life much easier.