Laboratory management of pharmaceutical companies under GMP system

The laboratory plays a crucial role in the pharmaceutical company’s production process. This article will delve into several key areas, including the development of a QC personnel training system, instrument maintenance, creation of comprehensive record management, establishment of laboratory data for Out of Specification (OOS) and Out of Trend (OOT), management of laboratory environment and hygiene, identification protocols within the laboratory, and effective sample management.

Establish QC personnel training system

Creating an effective training system for Quality Control (QC) personnel in a pharmaceutical laboratory involves a specialized approach due to the stringent requirements and regulations in the industry. Here’s a structured framework for designing a comprehensive training system:

Regulatory Compliance Training:

– GMP and GLP Training: Thorough understanding and continuous training on Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) specific to pharmaceuticals.

– FDA or EMA Regulations: Align training programs with specific regulatory guidelines from agencies like the FDA (U.S.) or EMA (European Union).

Technical Skills Development:

– Instrumentation Training: In-depth training on handling and maintaining sophisticated lab equipment used for testing and analysis (e.g., HPLC, GC, spectrophotometers).

– Analytical Techniques: Training on various analytical techniques like chromatography, spectroscopy, titration, and microbiological assays.

 Documentation and Compliance:

– SOP Familiarization: Training on Standard Operating Procedures (SOPs) related to sample handling, testing protocols, and documentation standards.

– Record-Keeping Training: Detail-oriented training on accurate and compliant documentation of test results, including data integrity principles.

 Quality Management System (QMS):

– Understanding QMS: Education on Quality Management Systems, including Change Control, CAPA (Corrective and Preventive Action), and Deviation Management.

– Risk-Based Thinking: Training to adopt a risk-based approach in QC processes and decision-making.

 Health and Safety:

– Lab Safety Training: Comprehensive training on handling hazardous materials, proper use of personal protective equipment (PPE), and emergency procedures.

– Handling Controlled Substances: Specialized training for handling controlled substances or potent compounds, if applicable.

Validation and Qualification:

– Method Validation Training: Understanding the principles and practices of method validation and analytical method transfer.

– Instrument Qualification: Training on instrument qualification and validation protocols.

 Continuous Improvement and Communication:

– Root Cause Analysis: Training on root cause investigation methodologies for addressing deviations or non-conformities.

-Communication Skills: Enhancing communication skills for effective reporting and documentation of findings.

 Role-Based Training:

– Job-Specific Training:*Tailoring training programs according to specific roles within QC (e.g., analysts, supervisors) to address their unique responsibilities.

 External Training Resources:

– Seminars and Workshops: Encouraging attendance at industry conferences, seminars, and workshops for exposure to the latest advancements and best practices.

Evaluation and Certification:

– Assessment Metrics: Regular evaluation of trainee competence through assessments, quizzes, or practical evaluations.

-Certification Programs: Recognition through certifications upon successful completion of training modules.

A structured and comprehensive training program for QC personnel within a pharmaceutical laboratory ensures not only compliance with regulations but also fosters a culture of excellence, accuracy, and continual improvement in testing processes and product quality.

Instrument maintenance

1. Instrument Training and Authorization: Before using any instrument, the laboratory must establish operational and maintenance procedures, providing training to relevant personnel. For high-precision or complex instruments carrying risks, authorized individuals should be trained to independently operate and maintain them.
2. Instrument Use and Record-Keeping: During operation, strict adherence to operational and maintenance procedures is vital. Timely completion of the “Experimental Instrument Usage Record” ensures traceability of instrument use.
3. Instrument Maintenance and Recovery: In case of equipment failure, marking it as inactive prevents accidental usage. Post-repair, the laboratory confirms the instrument’s status. Verification via measurement calibration or periodic checks ensures accuracy. Qualified results permit the resumption of normal use.
4. Management Beyond Laboratory Control: Instruments sent out for calibration, loans, or maintenance, not under direct laboratory control, require scrutiny upon return. Confirmation of appearance, including accessories, and functional status, along with accuracy verification if necessary, is essential before reinstating their use within the laboratory.
5. Establish original records management

Compliance with GMP demands meticulous handling of original records, ensuring timeliness, authenticity, accuracy, and completeness while preventing omissions or unauthorized alterations. Rigorous prohibition against forgery or data fabrication is paramount.

1. Identification: Establish unique identification using methods like numbering or color codes to distinguish records distinctly.
2. Storage: Classify and number records for easy retrieval and access. Specify detailed archiving and management protocols, including different management groups, assigned managers, and regular archiving intervals.
3. Clearly outline access permissions for personnel based on their roles and establish guidelines for record borrowing.
4. Protection: Implement measures for moisture, moth, and fire protection, guarding against loss, damage, or deterioration of records.

Safety and Confidentiality: Ensure records’ safety and confidentiality throughout their storage and handling.

5.Electronic Record Safeguards: Develop procedures for safeguarding and backing up electronic records.

6.Storage Duration: Clearly specify the duration for which records need to be retained.

7.Prompt Filing: Timely and regular filing of records in the Quality Assurance (QA) office is essential.

8. Disposal: Records disposal should only occur upon QA-approved procedures for destruction.

Establish laboratory data OOS, OOT

1. Investigate and track data anomalies that occur in the laboratory according to OOS and OOT, and according to the corresponding SOP. Treat abnormal situations that occur during experiments positively, and do not cover them up blindly, so as to standardize management.
2. During the experimental operation process and experimental record writing process, if the experimental personnel find that the experimental results or phenomena are different from the expectations, they must report it immediately.
3. After receiving the report, the person in charge should help the experimenter analyze the reasons. If experimental errors must be corrected immediately, the error results and correction process should be recorded in the experimental record and signed by the handling personnel for confirmation.
4. If the experimental operation error causes the experimental data to be unavailable, the error must be corrected after confirmation by the person in charge, and the experiment must be supplemented or re-experimented. Error experiment records cannot be deleted, and the cause of the error, problem analysis and solutions must be stated in the record.
5. Obvious laboratory errors and other obvious errors do not require investigation, but the relevant operations, phenomena, analysis processes and causes need to be recorded in detail in the original records, signed by the person in charge for confirmation, and the original data must be retained as available data. .
6. If the discoverer reports OOS/OOA/OOT or suspicious data, and it is confirmed by the person in charge, it will be processed in accordance with the relevant provisions of the “OOS/OOA/OOT or Suspicious Data Processing Procedures”.

Laboratory environment and hygiene management

1. Full-time personnel should be responsible for the hygiene of the laboratory clean area, and strictly implement experimental operating procedures and laboratory disinfection and sterilization methods. The laboratory should use special cleaning and sanitary tools that are free of falling objects, easy to clean and easy to disinfect, keep them properly, and disinfect them regularly; the laboratory should be cleaned without leaving any dead corners, and should be thoroughly cleaned once a week in conjunction with disinfection.
2. Before using the laboratory, users must follow the disinfection and sterilization procedures of the clean room and strictly clean the indoor ceiling, walls, floors, glass, doors, all instrument surfaces, indoor spaces, and items to be brought into the laboratory. The laboratory SOP carries out scientific and reasonable disinfection and sterilization to ensure that the environment of the clean laboratory meets the standards. The reagents used for cleaning work are prepared by the user.
3. Laboratory personnel must keep equipment and work areas clean and tidy at all times, and clean the work surface after work is completed. During experimental operations, develop rigorous operating habits, prevent experimental materials from splashing or atomizing, and resolutely prevent dripping solutions and reagents from contaminating or corroding the floor, tabletops, and instruments.
4. After use, biological waste or pharmaceutical raw materials and other waste items must be packaged on site and passed out through the delivery window. All used waste must be cleaned up and personalbelongings must be taken away.
5. After cleaning, you must fill in the instrument and laboratory usage record book and laboratory open record book in detail, and close the water, electricity, gas and doors.
6. All tissues, body fluid specimens or potentially infectious waste must be stored in durable, anti-diffusion containers and handed over to the center’s full-time sterilizers for high-pressure steam sterilization and harmless treatment. Prevent it from spreading into the environment and causing secondary pollution during collection, processing, operation, storage, transfer or transportation.
7. Air purification systems and equipment should be tested regularly, and indoor cleanliness should also be tested regularly.
8. Equipment, pipes and containers should be cleaned promptly after use and rinsed or disinfected with sterile water if necessary.
9. 9. The disinfectant used should not contaminate equipment, materials and finished products. Disinfectants should be replaced regularly to ensure disinfection effectiveness and prevent the development of drug-resistant strains.

Laboratory identity management

According to the different laboratory management objects, attribute identification and status identification are used to distinguish the management objects. According to nature, it can be divided into attribute identification and status identification. Attribute identification stipulates the inherent characteristics of things, which remains unchanged throughout the entire process and has the characteristics of uniqueness and traceability. Status identification refers to the ability of things to meet specified quality requirements when identifying. Generally, it has the characteristics of time limit and variability, that is, the identification object corresponds to different time periods and can have different states.

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Laboratory sample management

1. Prepare sample management procedures, which include receipt, disposal, protection, storage, retention, processing or return.
2. Sample receipt

Check the testing order/contract to ensure that the sample is consistent with the order requirements. Check the sample identification, sample volume/quantity, appearance, packaging and other information, record any abnormalities found in the sample registration form and communicate with the client in a timely manner.

3. Sample number identification
4. a) Uniquely identify the samples according to the requirements of the procedure documents and post the identification on the samples. Note that the numbering and posting method can be traced.
5. b) Sample circulation identification: Note that according to the status of the sample, it can be divided into four statuses: pending inspection, in inspection, inspection completed, and sample retention.
6. Management during the sample process
7. a) Identify sample storage requirements, and monitor, control and record sample storage conditions according to sample storage requirements.
8. b) During the circulation process, the relevant information of the samples shall be kept confidential in strict accordance with the requirements.
9. Sample retention and processing
10. a) The retention period of samples shall be given priority to comply with legal and regulatory requirements and customer requirements.
11. b) When not required by laws, regulations and customers, the sample retention time shall not be less than the dispute feedback time stated in the report.
12. c) For sample processing, customers can take back samples according to customer requirements.

Laboratory management is a complex system project. In order to ensure its healthy and orderly operation, it is necessary to pay close attention to the development of standards, policies and the application and development of new technologies.

Gaible, established in 2008 and headquartered in Shanghai, China,  specializes in offering comprehensive, intelligent management solutions for personnel in controlled environments, particularly excelling in personal protective equipment (PPE).

Recently, the company unveiled a 300-square-meter laboratory designed to replicate pharmaceutical production settings. This cutting-edge facility meets the rigorous standards of GMP sterile work areas, ensuring optimal indicators such as air cleanliness, temperature, humidity, air pressure, noise control, and microbial content. It achieves Class C and Class B cleanliness requirements in its core area.

The laboratory features a dedicated channel for professional dressing processes and offers customers teaching, training, assessment, and other services related to sterile changing, clean clothing management, and folding.

Innovatively, it incorporates a self-developed intelligent access control system, enabling personnel entry into clean areas through chip reading, QR code scanning on clothing, or iris recognition. This access control seamlessly integrates with the background management system, providing customers with operational demonstrations and personnel training for intelligent personnel management in clean environments.

Equipped with various testing and cleaning apparatus, the lab provides clothing testing services. The grade C area houses industrial-grade washing and drying machines and high-temperature sterilization cabinets for clean clothes. Services encompass product testing, verification, training, and assessment.

The laboratory utilizes specialized testing machines such as body-box and Helmke drum testers to assess clean clothes’ dust generation rates. Additionally, it employs filtration performance testers, fabric friction charge testers, and tensile testers to gauge cleanliness, barrier performance indicators, and material strength respectively.

The company emphasizes providing safe and reliable protection products and intelligent system solutions, delivering high-quality services throughout the supply, usage, testing, verification, and life cycle management phases. Their expertise lies in ensuring cleanroom safety and efficiency for their clientele.