12.2: QA/QC Documentation- SOPs, Batch Records, and COAs

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    Biotech Focus

    While the exact date of creation for the Standard Operating Procedure (SOP) is not known, there are some important historical milestones in its evolution. In the 1940s and 1950s, SOP-like procedures were used in military and manufacturing industries to ensure consistency and reliability in products and services used during WWII and the Korean war. In the 1960s and and 1970s, in response to regulatory oversight, SOPs became more common and more formalized in the pharmaceutical and medical industries. SOPs become embedded in most U.S.-regulated industries in 1978 with the publishing of Good Manufacturing Practices (GMP) regulations by the Food and Drug Administration (FDA). In the 1980s, SOPs became standard documentation used in ISO 9001 quality management systems. Since then, SOPs have been increasingly adopted across a wide range of industries, including biotechnology.

    Introduction

    In Quality Assurance (QA) and Quality Control (QC), documentation is essential to ensure processes are followed correctly and products meet required standards. Companies that have a quality management system (QMS) will incorporate specific documents into their system in order to ensure quality in all processes. In addition to these QMS documents, companies will create and use documents that are specific to their QA and QC processes.

    Learning Objectives

    QA and QC rely on appropriate documentation in order to assure themselves and their customers of their product and process quality. At the end of this page, you will be able to:

    • List some of the major documents used in quality management systems (QMS)
    • List some of the major documents used in quality assurance (QA)
    • List some of the major documents used in quality control (QC)
    • Explain the difference between a standard operating procedure (SOP) and work instructions
    • Explain the purpose of a batch record and list some of its components

    QMS Documentation

    ISO 9001 certification requires extensive documentation. These documents can ranges from ones that explain the company's commitment to quality to ones that track non-conformance issues and reviews management protocols. Some QMS documents required for ISO 9001 certification are:

    1. Scope of the QMS: Defines the scope of the QMS by detailing the products, services, and operations it covers
      • should specify which departments, processes, and locations fall under its scope
    2. Quality Objectives and Plans: Sets specific, measurable goals that support quality improvement in the company
      • outlines action plans, assigns responsibilities, and allocates resources so the objectives can be achieved
    3. Maintenance and Calibration Records: Tracks maintenance and calibration of equipment used in monitoring and measuring processes
      • should confirm compliance with industry standards
      • should include details of all approved calibration labs used - both external and internal labs
    4. Competence (Training) Records: Maintains training and competency records of employees to ensure they have the necessary skills for their roles
      • should document any additional training required for quality management
    5. Design and Development Records: Documents design inputs, outputs, controls, and modifications
      • should ensure all changes are evaluated and recorded to verify compliance
    6. Internal Audits: Documents the regular occurrence of internal audits to evaluate QMS effectiveness
      • should record findings, issues, and opportunities for improvement

    Quality Assurance (QA) Documentation

    Through QA documentation, the QA department can link processes to mistakes and defects in the hopes of improving performance and prevent future mistakes. These QA documents include:

    1. Quality Manual: a high-level document that outlines the company’s quality policies, objectives, and overall structure of the QA system
    2. Quality Plans: project- or product-specific plans that describe the quality standards, practices, and resources to be applied
    3. Standard Operating Procedures (SOPs): detailed, written instructions designed to ensure specific functions are performed consistently each and every time
      • can contains or refer to detailed work instructions
    4. Work Instructions: step-by-step guidance for performing a particular task or function
      • more detailed than SOPs
    5. Training Records: documents that outline staff training, qualifications, and competency evaluations
    6. Audit Plans and Reports: internal and external audit schedules, checklists, findings, and corrective actions
    7. Supplier Evaluation and Approval Records: criteria and documentation used to assess and approve suppliers providing materials and equipment
    8. Process Validation Reports: evidence that the processes used consistently produce the desired results

    Standard Operating Procedures and Work Instructions

    An Standard Operating Procedure (SOP) is a documented procedure that describes how a worker is to carry out a specific process or activity so that what is done is consistent across departments and shifts and is compliant with regulatory requirements and/or an organization's standards. An SOP focuses on a process and describes who does what, when, and why. An SOP is often part of regulatory or quality compliance by a company (e.g. ISO certification, FDA compliance). For example, a worker receiving incoming raw material into their company will use an SOP to ensure that the material meets quality standards before it is used in a process. This SOP might specify the following steps:

    1. receive materials from the shipping company
    2. inspect the material using established criteria
    3. document the receipt and inspection results
    4. approve or reject the raw material

    The SOP will often contain work instructions that provides detailed, step-by-step instructions on how to perform a specific task or activity. They are more granular than SOPs. Work instructions are used by frontline operators or technicians and focuses on a specific task. They often includes images, diagrams, tools needed. The work instruction describes exactly how to do something. For example, the worker receiving the raw material would follow a specific set of work instructions that details how move the material into the facility and where and how to store it. The work instructions would detail the exact steps the worker would use to inspect the material based on the SOP criteria. The work instructions would also outline how each document is to be completed and what the worker would do during accepting or rejecting the material.

    Table \(\PageIndex{1}\) below shows how SOPs and work instructions are related.

    Table \(\PageIndex{1}\): SOPs and Work Instructions
    SOP Work Instruction
    Receipt of raw material
    • Warehouse instructions:
      • Receive material from shipper
      • Verify the materials on the shipping receipt (i.e., packing slip) match what is being received
        • e.g. quantity,
      • Sign shipping receipt and make three copies of signed receipt
      • Record the type of packaging (e.g. styrofoam container, gallon drum) in the appropriate logbook
        • Place one copy of receipt in the warehouse shipment logbook; forward one copy to the purchasing department; forward one copy to the quality office
        • Alternative instructions (if applicable): digitally input receipt into the appropriate warehouse database and forward digital copies to the purchasing department and quality office
      • Assign a unique identification number for each material received and enter information into the appropriate logbook
      • Create an attach a receiving label to each material that contains the material name, the customer name, the date received, the internal ID number, the status of the material, the storage location of the material
      • Transfer the received materials to the inspection technician
    Inspection of material
    • Quality control instructions:
      • Inspect the received packages for unacceptable conditions like physical damage, moisture, mold, discoloration
        • For each material received, record each unacceptable condition in the appropriate log book
        • Document each unacceptable condition with photos, record in the appropriate logbook, and forward to the purchasing office
      • Verify that the receiving label generated by the warehouse technician includes at least the material name, lot/batch number, quantity, and customer name
      • Remove the Certificate of Analysis from each material and enter information into the appropriate logbook
        • Alternative: scan each Certificate of Analysis and enter into the appropriate database
        • Forward certificate data to the quality lab
      • Remove a sample from material and perform the appropriate QC tests
      • Record the QC results using the appropriate form (i.e. paper or digital)
      • Compare QC results with the Certificate of Analysis
      • Deem the material as acceptable or unacceptable
      • Store the material in the warehouse according to the material's requirements (e.g. store the material in the warehouse refrigerated room)
        • Segregate accepted and rejected materials into the correct areas of the warehouse
    Documentation
    • Warehouse logs (or software database):
      • raw material receiving logbook
      • identification number logbook
    • Inspection logs and reports (or software databases):
      • Condition logbook
      • Certification of Analysis logbook
      • QC testing report
      • Non-conformance logbook
    Accept/Reject
    • QC instructions:
      • If material passes QC tests, deem the material as acceptable, sign off and updates status of material to “Approved”
      • If material fails QC tests, deem the material as unacceptable, sign off and updates status of material to “Rejected”

    In summary, the SOP provides the framework and rules for how a process should be managed. Work Instructions provides the instruction for executing specific tasks in that process. Both are essential for a complete and effective quality system.

    Quality Control (QC) Documentation

    Using QC documents, the QC department identifies defects in products before they are shipped to customers. QC documents record these defects and are often forwarded to the QA department to determine if process improvements are needed. QA documents include:

    1. Inspection and Test Plans (ITPs): documentation of all inspections and tests required for each process or product
    2. Certificates of Analysis (COA): documentation provided by a company that verifies the quality and composition of a material or product
      • provides actual test results for specific attributes of a material, such as purity, strength, composition, and other relevant parameters
    3. Test Results: a record of test results confirming compliance (or non-compliance) with internal specifications outlined by the company
      • test results are compared to results provided in the COA
    4. Non-Conformance Reports (NCRs): documentation that reports any deviation from specifications or procedures
    5. Corrective and Preventive Action (CAPA) Reports: documentation of any action taken to fix quality issues and prevent recurrence
    6. Sampling Plans and Records: records that outline guidelines and evidence for product sampling and testing
    7. Calibration Records: records that provide verification that measurement equipment is accurate and traceable
      • verification can be done internally or externally
    8. Batch Records/Lot History Records: traces production and QC activities for each batch/lot of material used
    9. Control Charts and Statistical Process Control (SPC) Data: used to monitor and control processes over time

    Batch Records

    A batch record is a comprehensive written (or digital) document that is used in a manufacturing processes to record the production details of a specific batch of a product. Batch records are commonly used in industries like pharmaceuticals, biotechnology, food production, and cosmetics. The batch record is not only a quality document that ensures traceability and consistency, but is a legal, compliance document for FDA regulatory standards or ISO requirements.

    The batch record is used to standardize batch production, ensuring that each batch is made consistently, following approved procedures. It is used to trace or track the history of every batch for recalls, investigations, or audits. The batch record is part of quality assurance is it confirms that the product meets quality and safety standards. It is required by regulatory bodies during inspections. Finally, it is used to train new employees on proper procedures and standards.

    A batch record contains the following:

    1. Batch identification
      • Batch/Lot number
      • Product name and code
    2. Manufacturing instructions
      • Raw materials and quantities in the product
      • Equipment and settings used in the creation of the product
      • Processing steps and timelines required for manufacturing of the product
    3. Personnel and responsibilities
      • Operator and supervisor signatures
      • Dates and times of each manufacturing step
    4. Quality control checks
      • In-process test results for specific manufacturing steps
      • Final product specifications
      • Deviations and corrective actions (if applicable)
    5. Environmental conditions
      • Temperature, humidity, or other required conditions for storing and using the product
    6. Packaging and labeling details
      • Type and quantity of packaging materials
      • Label batch codes

    Companies will create and use a Master Batch Record (MBR) which is a standardized template or approved instruction set for manufacturing and testing a product. The MBR is used to ensure consistent production across all batches. The completed version of a batch record that captures the actual data and observations for a specific batch is called an Executed Batch Record (EBR). The EBR reflects what actually occurred during manufacturing. Today, many companies are now moving from paper-based to Electronic Batch Records (eBRs) for better efficiency, error reduction, and real-time tracking.

    Certificate of Analysis (COA)

    A certificate of analysis (COA) is a document that is validated and issued by a QC laboratory or QA department. It is required under Good Manufacturing Practices (GMP) and ISO standards and is subject to inspection by regulatory bodies like the FDA, EMA, or Health Canada. The COA confirms the identity, strength, purity, and quality of a product or raw material. The COA will include key test results for these parameters obtained through analytical methods. The COA is a key part of a batch release decision in which the product is approved to be used in a company's production process. A QA department uses the COA to determine if a batch is suitable for release into a company's production line or should be referred to the QC department for additional testing or investigation. Issues with the information provided in the COA can result in rejection of the material by the QA department before it is used. The COA is also a key part in supply chain communication. By creating a COA, a company can share important information with customers, regulators, or partners about their product in order to provide confidence in their product's quality. The COA provides traceability. It helps a company maintain a record of product performance and compliance for audits or recalls. Finally, the COA is used by QC department in raw material testing. Suppliers provide COAs to verify raw materials meet a company's specifications before it is used in manufacturing. The QC department can test raw materials and compare their results to those listed in the COA. Discrepancies between the COA and the QC test results can result in rejection of the material.

    The components of a COA can be determined by the industry or by regulatory bodies. However, a typical COA includes:

    1. Product and batch information
      • Product name and code
      • Batch or lot number
      • Manufacturing and expiry dates
    2. Specifications and test parameters
      • Physical and chemical tests (e.g., appearance, pH, assay)
      • Microbiological testing (if applicable)
      • Specification limits or acceptance criteria
    3. Actual test results
      • Quantitative or qualitative results for each parameter
      • Units of measurement (e.g., %, ppm, CFU/g)
    4. Compliance statement
      • A declaration that the product "meets" or "does not meet" specification requirements
    5. Signature by authorized QC or QA representative and date
    6. Laboratory or company information
      • Name, address, and contact details of the external testing lab or the manufacturer used for testing

    QA and QC Documents

    Some documents are used in both QA and QC. These documents are:

    1. Change Control Records: a document that outlines any planned or actual changes to processes, equipment, materials, documents, or systems that could affect quality or compliance
    2. Risk Assessment Analysis and Plans: a document that identifies and evaluates potential risks to product quality, safety, or compliance
      • also outlines measures to mitigate or eliminate these risks
    3. Customer Complaints and Feedback: documented reports from customers regarding product issues, dissatisfaction, or improvement suggestions
      • used to identify areas of non-compliance
    4. Regulatory Compliance Records: records that show how an organization complies with applicable laws, regulations, and industry standards
      • e.g., compliance to FDA, ISO, GMP, OSHA standards and regulations
    Key Concepts

    Documentation is a key part of quality assurance and quality control. Some important concepts to remember are:

    • Quality Management System (QMS) documents include the scope of the QMS, design and development records, and validation reports
    • QA documents provide customers with an assurance of a product's quality
    • QA documents can link processes to mistakes and defects in the hopes of improving performance and prevent future mistakes
    • QA documents include the quality manual, standard operating procedures (SOPs) and work instructions
    • QC documents include batch records and certificates of analysis
    • Batch records and certificates of analysis have required components product name, product ID code, and batch code
    • a batch record documents the production process and quality checks for a specific batch of product
    • a certificate of analysis (COA) is issued by a company's QA or QC department to confirm that a product meets all predefined specifications

    Glossary

     

    Audit report - an electronic or manual log that tracks all changes, deletions, or additions to a document or system, ensuring transparency and traceability

    Batch Record (BR) - a detailed document that records the production process and quality checks for a specific batch (i.e., lot) of product.; includes the raw materials, equipment used, personnel involved, and results of in-process tests

    Batch release - the formal process of approving and releasing a batch of product for distribution or sale, after it has successfully passed all required quality, safety, and compliance checks

    Certificate of Analysis (CoA) - a document issued by QA or QC that certifies a batch meets all predefined specifications

    Change Control - a formal process used to request, assess, approve, and document changes to procedures, equipment, or systems; may impact product quality or compliance

    Corrective and Preventive Action (CAPA) - a documented process used to investigate, correct, and prevent the recurrence of deviations, non-conformities, or failures

    Deviation - a documented instance where a process or result does not follow the approved procedure or expected outcome

    Executed Batch Record (EBR) - the completed version of a batch record that reflects what actually occurred during manufacturing and captures the actual data and observations for a specific batch

    Logbook - a chronological record used to document equipment usage, maintenance, calibration, or other quality-relevant activities

    Master Batch Record (MBR) - a standardized template used in manufacturing and testing a product to ensure consistent production across all batches

    Non-Conformance Report (NCR) - a formal document used to report instances where a product or process does not meet specifications or regulatory requirements

    Quality Manual - a top-level document that outlines an organization's quality policies, objectives, and the structure of its quality management system (QMS)

    Standard Operating Procedure (SOP) - a detailed, written instruction describing how to perform a routine or repetitive activity in a consistent and controlled way; ensures compliance, training, quality, and safety

    Supply chain - the network of people, organizations, activities, information, and resources involved in producing and delivering a product or service from raw materials to the end customer

    Traceability - the ability to track and trace the history, application, location, or use of a product, material, or component from its origin to its end use

    Validation - the process of proving that a system, process, equipment, or method consistently produces results that meet predefined quality standards

    12.2: QA/QC Documentation- SOPs, Batch Records, and COAs is shared under a CC BY 4.0 license and was authored, remixed, and/or curated by LibreTexts.