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Requirements of Schedule L1 (Indian GLP) Good Laboratory Practice in Pharmaceutical


Learn about Good Laboratory Practice to be followed by the drug manufacturers in India.i.e Schedule L1.

Schedule L1 is Good Laboratory Practices and Requirements of Premises and Equipments. 

Following is the brief description of the parts of the schedule L1.

1. General Requirements:- 

It includes the general requirements of a quality control laboratory as qualification of management and quality control manager preparation of quality audit schedules and responsibilities of manager.

2. Premises:- 

It includes designing, walls, floor, ceilings and lighting system in the laboratory. It also includes the directions about animal house.

3. Personal:- 

Necessary qualification of laboratory staff and their training and records are described in this section.

4. Equipments:- 

Equipment, their maintenance and calibration records are included in this section of schedule L1.

5. Chemicals and Reagents:- 

This section contains Chemical handling, stock solution preparation and volumetric solution standardization records.

6. Good house keeping and safety:- 

Instructions about safety and drinking, eating and smoking in laboratory, protective clothing, first aid techniques, warnings, precautions, and written instructions, storage, and disposal of wastes are given in this section.

7. Maintenance, calibration, and validation of equipments:- 

This section contains frequency of calibration, Standard Operating Procedures for calibration and calibration schedule and laboratory logbooks. 

8. Reference materials:- 

Preparation instructions and storage of reference standards are described in this section.

9. Microbiological Cultures:- 

This section contains maintenance, sub-culture and destruction of microbial culture.

10. Quality system:- 

Quality policy for the organization, detection and corrections, internal andexternal audits are explained in this section of schedule.

11. Internal quality system audits:- 

Requirements of quality system and requirements of regulatory authorities, records of the analysis and other Quality related documents.

12. Management review - 

Report or input of internal audits are given in this section.

13. Standard Operating Procedures:- 

This section is consist of handling and accountability, record keeping, reporting, storage and retrieval of data, routine inspection of cleaning, maintenance, testing, calibration and standardization of instruments and use and storage of reference standards.

14. Protocols and specifications archive:- 

Specification, updates and corrections in validated test methods are given in this section.

15. Raw data:- 

This section of schedule contains laboratory work sheet, recorded data from automated equipment, data integrity and security.

16. Storage and archival:- 

Residual sample storage condition, collection, indexing, retrieval, storage, maintenance, and disposal of all quality documents are described in this section.

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


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