Laboratories Limited Corporate QA

CHECK LIST FOR AUDIT PREPARATION DEPARTMENT: CORPORATE QUALITY ASSURANCE

S. No
1. 2. 3. 4. 5. 6. 7. 8. 9. 1 0. 1 1. 1 2. 1 3. 1 4. 1 5. 1 6. 1 7. 1 8. 1 9. 2 0. 2 1. 2 2. 2 3. 2 4. 2 5. 2 6. 2 7. 2 8.

Department / Area
Engineering Engineering Engineering Engineering Engineering Production Production Production Production Production Production Production Production Production Production

Subject / Topic
Equipment Qualifications Preventive Maintenance / History cards AHU / HVAC Calibrations Water Validations Process Validations of Audit products Packing batch records Batch Production records (Running) Cleaning validations Product change over records Recovery solvent consumption usage and

Responsibility

Remarks (Completed / Not completed

Mr.Raghuram/Adhir

Mr. Syed/Raghuram

Line clearance procedure if any Area cleaning / equipment cleaning Malfunction & breakdown handling Reprocess / rework

Quality Quality Quality Quality Quality Quality Quality Quality Quality Quality Quality Quality

Current batch production records for dispatched products Contract manufacturing approach Contract Testing labs qualifications Site Inspections history Rejections handling Validation Master Plan Site Master File Organogram / Job descriptions Dispatch Reconciliation Records Annual Products reviews Technical Staff details Water Validations & Qualifications, Microbial testing of water Mr. Adhir Mr. Adhir / Mr. Raghuram Mr. Adhir Mr. Adhir Mr. Raghuram/ Adhir Mr. Rajeswar Mr. Adhir/Rajeswar

Page 1 of 3

Laboratories Limited Corporate QA

CHECK LIST FOR AUDIT PREPARATION DEPARTMENT: CORPORATE QUALITY ASSURANCE

S. No
2 9. 3 0. 3 1. 3 2. 3 3. 3 4. 3 5. 3 6. 3 7. 3 8. 3 9. 4 0. 4 1. 4 2. 4 3. 4 4. 4 5. 4 6. 4 7. 4 8. 4 9. 5 0. 5 1. 5 2.

Department / Area
Quality Quality Quality Quality Quality Quality Quality Quality Quality Quality Quality Quality Quality Control Quality Control Quality Control Quality Control Quality Control Quality Control Quality Control Quality Control Quality Control Quality Control Stability Stability

Subject / Topic
Environmental Monitoring Culture and media storage handling Training records Change controls Deviations OOS Failure Investigations CAPA Self Inspections Packing material testing Vendor Qualification Contract testing Market complaints / Returns Spec / STP for Audit Products Method transfer documents Analyst validations Part 11 compliance Reserve Samples / Control samples Electronic data back-up Lab instruments qualifications Lab instruments calibrations and standard traceability In-process controls and raw data verification Working / Reference standard management Stability Raw Data Stability chambers qualification and data logging mechanism and and

Responsibility

Remarks (Completed / Not completed

Mr. Raghuram Mr. Raghuram

Mr. Rajeswar & Team

Mr.Raghuram Mr. Rajeswar & Team Mr. Adhir

Mr. Rajeswar & Team

Page 2 of 3

Laboratories Limited Corporate QA

CHECK LIST FOR AUDIT PREPARATION DEPARTMENT: CORPORATE QUALITY ASSURANCE

S. No
5 3. 5 4. 5 5. 5 6.

Department / Area
Stores Stores Stores Stores

Subject / Topic
Warehouse Practices FIFO deviations addressing

Responsibility

Remarks (Completed / Not completed

Mr. Raghuram Storage and distribution system Starting materials stock & status verification

Page 3 of 3