1. should be cleaned before beginning an experiment
2. What is GLP?
2.1. deals with:
2.1.1. organisation
2.1.2. process
2.1.3. conditions under laboratory studies
2.1.3.1. planned
2.1.3.2. performed
2.1.3.3. monitored
2.1.3.4. recorded
2.1.3.5. reported
2.2. Involves practices in the Quality Control Lab
2.2.1. undertaken to carry out an analysis
2.2.1.1. with a defined degree of
2.2.1.1.1. accuracy
2.2.1.1.2. precision
3. importance
3.1. released based on the analytical results
3.1.1. raw materials
3.1.2. packaging materials
3.1.2.1. generated in the QC lab
3.1.3. intermediates
3.1.4. finished products
3.2. ACCURACY,
3.3. PRECISION
3.4. RELIABILITY
4. assure regulatory authorities
4.1. data submitted are a true reflection of the results
4.1.1. be relied upon when making risk/safety assessments
5. notebooks
5.1. Establishing good work practices
5.2. Knowledge retention & sharing in the lab
5.3. Meeting contractual requirements
5.4. Avoiding fraud
5.5. Defending patents
5.6. patent record, "original" record
5.6.1. first human-readable form("original" record
5.7. witness
5.7.1. Patent related businesses require all notebook to be witnessed
5.7.2. When you think you have conceived an invention or an idea that my have intellectual property value, the date you did so is when you want a witness
5.7.3. A witness serves a certifying function but not a coinventor who has a vested interest in verifying claim.
5.8. storage
5.8.1. protected from the risk of damage and contamination
5.8.2. should be indexed and kept in a safe central repository (completed notebooks)
5.8.3. kept for the life of the patent plus six years (patent purposes)
6. laboratory techniques
6.1. cleaning glassware
6.1.1. Clean with detergent
6.1.2. Rinse several times with tap water
6.1.3. Final rinse with deionised water
6.1.4. Inspection: Water droplets do not adhere to the wall of clean glassware
6.1.5. Invert clean glassware for drying
6.2. Inserting Glass Tubing through a Rubber Stopper
6.2.1. Moisten glass tubing and rubber hole with water or glycerol
6.2.2. Protect hand with cloth towel
6.2.3. Twist & push the tubing slowly and carefully
6.3. Handling Chemicals
6.3.1. Read Material Safety Data Sheet (MSDS) before handling any chemical
6.3.2. Read the label (labelled according to the National Fire Protection Association
6.3.3. Dispense the amount of what you need.
6.3.4. Never touch, taste, smell chemicals unless specifically directed to do so
6.3.5. Properly dispose of chemicals
6.4. Transferring Solids
6.4.1. Read Label to confirm the correct chemical
6.4.2. Place the stopper or cap of reagent bottle top side down
6.4.3. Use a clean spatula or scoop for transferring solids
6.5. Transferring Liquids and Solutions
6.5.1. Transfer the liquid from a reagent bottle with the aid of a stirring rod or spatula
6.5.2. The rod should touch the lip of the transferring vessel and the inner wall of the receiving vessel
6.6. Disposing of Chemicals
6.6.1. Proper disposal of chemicals is available from Material Safety Data Sheet (MSDS)
6.6.2. Read the label on the waste container carefully before discarding the chemical waste
6.6.3. Nothing (besides soap and water) is to be discarded in the lab sink
6.7. Measuring Mass
6.7.1. Handle with care
6.7.2. Level the balance before use
6.7.3. Do not place chemicals directly on the balance pan
6.7.4. Do not drop anything on the balance pan
6.7.5. After completing a mass measurement, return the mass settings to the Zero position
6.7.6. Clean the balance and balance area of any spilled chemicals.
6.8. Measuring Volume
6.8.1. Reading and Recording a Meniscus
6.8.2. Pipetting a Liquid
6.8.3. Titrating a Liquid/Solution
6.9. Preparing Solutions
6.9.1. Place water (or the less concentrated solution) into volumetric flask until it is one-half full
6.9.2. Add solid (or the more concentrated reagent) slowly to the volumetric flask
6.9.3. Dissolve the solid compound or mix the solution via swirling.
6.9.4. Add water (drop-wise if necessary via a dropper) until the calibrated “mark” etched on the volumetric flask is reached.
6.9.5. While securely holding the stopper, invert the flask slowly 10-15 times to ensure good mixing.
6.10. Separating a Liquid or Solution
6.10.1. Gravity Filtration
6.10.1.1. filtrate
6.10.1.1.1. The solution that passes through the filter in a filtration procedure.
6.10.2. vacuum filtration
6.10.3. Centrifugation
6.10.3.1. Supernatant
6.10.3.1.1. Clear liquid covering a precipitate
6.11. Heating Liquids and Solutions
6.11.1. Naked flame from Bunsen burner MUST be handled with extra care!
6.12. Evaporating Liquids
6.12.1. carried out in a fume hood.
6.12.2. The flammability of the liquid MUST be considered for safety precaution.
6.13. Heating Solids
6.13.1. Heating in a drying oven
6.13.2. Cooling in a Desiccator
6.13.3. Using a Crucible
6.14. Venting Gases
6.14.1. using a fume hood
6.14.1.1. Turn on the hood air flow (at least 0.5m/s) prior to initiating any experiment
6.14.1.2. Never place your face inside of the fume hood with on-going experiment
6.14.1.3. Never set the equipment or chemicals near the edge of fume hood
6.14.1.4. Do not crowd experiment set up in a fume hood
6.15. Separating a Liquid or Solution
7. lab data management
7.1. FDA comments on data security & authenticity
7.1.1. Only authorized individuals can make data entries
7.1.2. No data can be deleted. Changes make through amendments
7.1.3. Database must be tamperproof
7.1.4. SOP must describe the procedures for ensuring the validity of the data
7.2. Security
7.3. System operations
7.4. Data archival & retrieval
7.5. Training
7.6. maintenance
7.7. change control
7.8. `lab info management system (LIMS)
7.8.1. a computer application designed for the analytical laboratory that is designed to
7.8.1.1. administer samples
7.8.1.2. acquire and manage data
7.8.1.3. report results via a database
7.8.2. automates the process of sampling, analysis and reporting and in its simplest concept
7.8.3. LIMS can be used to
7.8.3.1. Receive, Log in, Label samples, Track records & Specimens
7.8.3.2. Assign & Schedule work
7.8.3.3. Integrate data collection by interfacing with instrument
7.8.3.4. check status of work
7.8.4. Out-of-specification (OOS)
7.8.4.1. Informal investigation
7.8.4.1.1. Single-event OOS
7.8.4.1.2. Departmental level
7.8.4.1.3. Must be documented
7.8.4.1.4. Trigger the review of test procedures, calculations, equipment performance and data record
7.8.4.1.5. If problem resulted OOS identified, initial OOS invalidated, the test is repeated
7.8.4.1.6. The repeat test is NOT considered a retest
7.8.4.1.7. If initial OOS is not invalidated, then manager/director must be involved
7.8.4.1.8. ◦ Formal investigation initiated
7.8.4.1.9. Other areas to cover
8. Introduction to International Lab Quality Standards
8.1. ISO 9001 Standard
8.1.1. ISO forms the specialized system for worldwide standardization
8.1.2. It is designed for companies and organizations that do design and development of their products or services as well as the production and delivery of them.
8.1.3. The organization shall establish, document, implement and maintain a quality management system and continuously improve its effectiveness
8.2. ISO17025
8.2.1. International Standard that specifies the general requirements for the competence to carry out tests and/or calibrations
8.2.2. applies to all organizations performing tests and/or calibrations
8.2.3. How does a laboratory get accredited to ISO17025
8.2.3.1. Document a quality management system(QMS)
8.2.3.2. Establish quality management procedures to maintain the system
8.2.3.3. Implement the QMS in the laboratory several months to establish the records that an accreditation body will review at an accreditation audit
8.2.3.4. the laboratory undergoes the ISO17025 assessment by an accreditation body that is certified to perform laboratory accreditation
8.3. ISO14000
8.3.1. a management tool enabling an organization of any size or type to
8.3.1.1. Identify and control the environmental impact of its activities, products or services
8.3.1.2. Improve its environmental performance continually, and to
8.3.1.3. Implement a systematic approach in setting environmental objectives and targets, to achieving these and to demonstrating that they have been achieved
9. Good Manufacturing Practice
9.1. Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act.
9.2. force of law
9.2.1. require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective
9.3. quality approach
9.3.1. manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors
9.3.1.1. protects the consumer from purchasing a product which is not effective or even dangerous
9.4. Failure of firms
9.4.1. result in very serious consequences including recall, seizure, fines, and jail time
10. Regulatory Requirements for Lab Control
10.1. Compliance with regulatory requirements in the following
10.1.1. Management systems
10.1.2. Operating procedures
10.1.3. Personnel training
10.1.4. Data accountability
10.1.5. Method validation
10.1.6. Equipment
10.1.7. Facilities
10.1.8. Documentation
11. Documentation Control
11.1. shall establish and maintain procedures to control all documents that form part of its management system, internally generated or from external sources.
11.2. definition of "document"
11.2.1. Could be policy statements, standard operating procedures, lab procedures, equipment manuals, test specifications, instrument calibration tables, charts, text books, posters, notices, memoranda, software, drawings, plans, etc.
11.2.2. These may be on various media, whether hard or copy or electronic, and they may be digital, analog, photographic or written.
11.3. Document approval & issue
11.3.1. All document issued to the lab as part of the management system shall be reviewed and approved for use by authorized personnel prior to issue.
11.4. Document Change Control
11.4.1. All document changes hall be reviewed and approved by authorized personnel prior to implementation.
11.5. Control of Records
11.5.1. Lab shall establish & maintain procedure for identification, collection, indexing, access, filing, storage, maintenance & disposal of quality and technical records for audit trail.
11.5.2. Quality system related
11.5.2.1. Organisation chart,
11.5.2.2. Change control records,
11.5.2.3. staff records,
11.5.2.4. audit reports,
11.5.2.5. corrective action report
11.5.2.6. preventive action report
11.5.2.7. management reviews
11.5.2.8. deviation reports, etc.
11.5.3. Technical related
11.5.3.1. Lab notebooks
11.5.3.2. records of original observations
11.5.3.3. derived data
11.5.3.4. calibration records
11.5.3.5. instrument print-out
11.5.3.6. chromatograms
11.5.3.7. maintenance records
11.5.4. All records shall be held secure & in confidence
11.5.5. Lab shall established procedure to protect & back-up records
11.5.5.1. To prevent damage or deterioration
11.5.5.2. To prevent loss
11.5.5.3. To prevent unauthorised access or amendment
11.5.5.4. To define retention times of records
12. Applications of GLP in Testing Services
12.1. Differential Scanning Calorimetry
12.1.1. a thermoanalytical technique in which the difference in the amount of heat required to increase the temperature of a sample and reference are measured as a function of temperature. Both the sample and reference are maintained at nearly the same temperature throughout the experiment
12.1.2. Glass transition
12.1.2.1. transformation of a glass-forming liquid to glass, which usually occurs upon rapid cooling. It is a dynamic phenomenon occurring between two distinct states of matter (liquid and glass), each with different physical properties