This slide will give you brief idea about different types of laboratory control records used in pharmaceutical industries & where it is used. I hope this will help you a bit . For any corrections, do not hesitate to comment down below.

1. LABORATORY CONTROL RECORDS
Vinit Gohel
2061615005
M.Pharma (Pharmaceutical Analysis)

2. The Difference Between Documentation And Records

3. Importance Of Laboratory Documents
• Essential guidelines for the laboratory in the form of a quality manual, sops and reference material. They are
required part of the laboratory quality standards.
• Reflects the laboratory's organization and quality management.
• Laboratories maintain documents and records to find information when it is needed.
• Maximum time verbal instructions often go unheard, or are misunderstood, quickly forgotten, or difficult to
follow.

4. Laboratory Documents
• Quality Manual
• Sops
• Controlled Documents
• Personnel Files
• Instrument Files
• Equipment Maintenance
• Calibration And Verification
• Quality Control
• Temperature And Humidity Logs
• Test Tracking System
• Proficiency Testing, And Quality Assessment.

5. Quality Manual
Outline of a quality manual
 Introduction
 Organization and management
 Quality policy
 Personnel (staff education and training )
 Document control, including records, maintenance and
archiving
 Accommodation and environment
 Instruments, reagents, consumables management
 Safety
 Research and development (optional)
 Pre-examination procedures
 Examination procedures
 Post-examination procedures
 Quality control
 Laboratory information system
 Handling of complaints - occurrence management
 Communications and other interactions
 Preventive and corrective action, internal audit
 Ethics

6. Quality Manual
• It is a roadmap for meeting the quality systems requirement.
• Indication of the management's commitment to quality.
• There should be only one official version of quality control manual.
• Should be improved on an ongoing basis.
• Should be read and accepted by everyone.
• Should be in clear language.
• Should provide uniformity in testing over time, and from one person to the next.

7. SOPs
• Should contain step by step instructions on how to perform a test
• Should be consistent, accurate and of high quality
• Should be easily understood by new staff
• Should be reviewed and approved by management
• Should be updated regularly
• Should not drown the details
• SOP for routine inspection, cleaning, maintenance, testing, and calibration.

8. Controlled Documents
• SOPs, texts, articles, reference books, equipment service manuals, regulations, and standards.
• Have a system in place for organizing, approval, and revision.
• Maintain a master log that describes the documents in circulation.
• Should be accessible at the point of use.
• Should have an archiving system.

9. Instrument Files
• Instrument Name
• The Model Number And Serial Number
• Purchase Date
• Manufacturer and/or Supplier Contact Information
• Technical Service Contact Information
• Repair Service Contact Information
• Warranty Information
• Preventive Maintenance And Repair Services Performed By Company Representatives
• Verification Of Performance Specifications, If Applicable

10. Proficiency Testing (PT)
• A copy of the PT enrollment order form.
• The instructions that come with the samples.
• All worksheets and instrument printouts of testing.
• A copy of the final completed result form that you send to the PT provider, including the signed attestation
statement.
• The reviewed PT score report, including the CMS summary page.
• Documentation of investigations and corrective actions for any PT failure.

11. Quality Control (QC)
• Quality control results
• Graph quantitative results for visual evaluation of shifts and trends over time
• Recognized problems and corrective actions to address them
Test Tracking System
• Test requisitions
• Testing records
• Test reports

12. Various Other Documents
• Personnel files-education, experience, training, and continuing education
• Equipment maintenance-sops, maintenance logs
• Calibration and calibration verification
• Temperature and humidity logs
• Quality assessment (QA)

13. Laboratory Records That Should Be Kept
Guidelines Description
Section 211.67(c) Maintenance, cleaning, sanitizing, and inspection
Section 211.68(a)
Calibration checks, inspections, and computer or related system programs for automatic, mechanical,
and electronic equipment.
Section 211.68(b)
All appropriate controls must be exercised over all computers or related systems and control data
systems to assure that changes in master production and control records or other records are instituted only
by authorized persons.
Section 211.105(b)
Major equipment must be identified by a distinctive identification number or code that must be recorded
in the batch production record to show the specific equipment used in the manufacture of each batch of a
drug product.
Section 211.160(a)
Establishment of any specifications, standards, sampling plans, test procedures, or other laboratory
control mechanisms, including any change. Must be drafted by the appropriate organizational unit and
reviewed and approved by the QC unit. Any deviation from the written must be recorded and justified

14. Laboratory Records That Should Be Kept
Guidelines Description
Section 211.194
Describes laboratory records that must be retained.
Section 211.182
Specifies requirements for equipment cleaning records and the use log.
cGLPs Intended to assure the quality and integrity of non-clinical laboratory studies.
21 CFR part 58
Good laboratory practice for nonclinical laboratory studies.
40 CFR part 160 FIFRA Protection of environment, good laboratory practice standards.

15. Records Retention And Document Controls
Electronic-records/signatures must be equivalent to paper records/sigs
Procedures and controls must include:
• Systems validation
• Protection of records throughout the retention period
• Limited systems access
• Time-stamped audit trails
• Systems, Authority, and Device checks
• Personnel who have adequate training & experience
• Control over system documentation

16. Documentation Best Practices, Storage And Retention
• Whether electronic or paper, documents must be clear, concise, user-friendly, explicit, accurate, and up-to-date.
• Draft documents must be compliance with established standards.
• Update documents and maintain records regularly.
• Use the most current version.
• Document preparation and control process includes the following in sequence
• Prepare
• Review
• Revise
• Approve
• Distribute
• Retain things you might forget.
• Documents should permit the complete reconstruction of a study.
• Properly head all pages, tables, columns; identify units .
• Describe Statistical & Calculation Procedures used .
• Sign, Date, and File automated printouts.

17. Storage
• Documents must be stored in an orderly manner.
• Laboratory director, the laboratory consultant, inspectors, and accreditation agency surveyors should be able
to promptly retrieve documents.
• Ensure that all documentation is maintained for the proper length of time.
• Most documents and records generated in the laboratory must be available for two years.
• Some must be stored for a longer time period.

18. References
• https://www.complianceonline.com/resources/quality-control-laboratory-compliance-documentation-and-
record-keeping-explained.html
• https://www.fda.gov/
• https://isoindia.org/
• https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=211.194

19. Thank You