| Approval and Analysis from Contract Testing Laboratory |
1.0 OBJECTIVE To lay down the procedure for Approval and analysis from contract testing laboratory. 2.0 SCOPE This SOP is applicable for Approval and analysis from contract testing laboratory in quality control department. 3.0 RESPONSIBILITY QC – Officer/ Sr. Officer /Executive/Sr. Executive and above. 4.0 ACCOUNTABILITY Head-QC 5.0 PROCEDURE 5.1 Select laboratories for contract analysis available on the basis of easy approachable, reputed in the market, past history etc. 5.2 Send them questionnaire attached as Format no. XXX. and ask them for following document but not limited to: 5.2.1 Approval certificate from government (license copy) 5.2.2 Any other approval from regulatory authorities if any 5.2.3 List of instruments 5.2.4 Quality policy 5.2.5 Quote of analysis 5.2.6 List of technical staff (Approved and non-approved but internally qualified) 5.2.7 List of working and reference standard etc. 5.3 After receiving above mentioned documents evaluate the facility based on the information furnished by the laboratory against GLP requirement and requirement of analytical support required. 5.4 If information provided found satisfactory, then a site audit shall be conducted by competent technical staff or team of QC and QA as per checklist QC01-040/F02. 5.5 Auditor shall audit the facility and observation shall be recorded. He/She shall perform audit as per checklist simultaneously based on his experience and regulatory requirement, audited also evaluate the procedures, equipment/instrument and facility. 5.6 Evaluation: 5.6.1 After completion of audit, auditor shall share the observation with audited. 5.6.2 An audit report shall be prepared by auditors within a week, which shall be discussed with QA-head/Designee. 5.6.3 Based on the criticality the non-compliances shall be categories into following three categories; 5.6.3.1 Critical: Deficiencies which have a high probability of causing adverse consequences to the patient or consumer; may result in significant deviations in the safety, identity, strength or purity of the product and raw material ; or are a combination of major deficiencies which indicates a critical system failure in quality control department. 5.6.3.2 Major: Deficiencies which could potentially cause adverse consequences to the patient or consumer if left un-addressed, could be considered indicative of poor control, could be considered major deviations by regulatory authorities, or a combination of minor deficiencies which indicate a major systems failure in quality control lab, or a number of repetitive minor deficiencies. Requires CAPA’s to be agreed although analysis may be carryout at the concern laboratory. 5.6.3.3 Minor: A deficiency which cannot be classified as critical or major. Requires CAPAs to be agreed although operations can proceed in quality control department. 5.6.4 Audit report shall be sent to the concern laboratory for compliance. 5.7 Approval criteria: 5.7.1 Parameters shall be rated as A, B, C and D based on impact of the observation on analytical results and GLP. 5.7.2 Rejection and approval of site depend up on the overall rating as per scoring criteria given below; 5.7.2.1 A-Excellent NLT 80.0% 5.7.2.2 B-Good NLT 70.0% 5.7.2.3 C-Satisfactory NLT 60.0% 5.7.2.4 D- Rejected less than 60.0% 5.8 After approval a technical agreement shall be prepared by us with contract laboratory including the terms and conditions set by our organization (Sigma Softgel Pvt. Ltd.) adhered by the contract laboratory during their contract period. 5.9 Technical Agreement shall be signed off by the technical representative of the contract laboratory as well as of our Organization. 5.10 Only approved laboratories shall be used for analysis of samples. 5.11 Sample sending procedure: 5.11.1 Respective sample shall be packed properly with appropriate labeling and fill the Format No. QC01-040/F03 and sent (Sr. No., Date, Product Name, Batch No., Details of Analysis, Sample Send by, Report Received by, &Remark) in “Out Side Sent Sample Inward Register.” 5.11.2 When sample sending by Q.C outside then fill details Non-Returnable Gate Pass and sign all person, then send on gate. If Outside lab already gave our “Test Request Slip” then not necessary fill NRGP, only gave first copy of TRS to gate for entry and then maintain Format No. QC01-040/F03. 5.11.3 When sample sent to outside laboratory for testing then sample details mentioned in “Test Request Slip” as per Format No. QC01-040/F04 5.11.4 The sample along with the test request form, Specifications and Method of analysis (if Non-Pharmacopeias) is sent through courier, scan copy by email or the field representative of respective Lab collect the sample from the company premises. 5.11.5 After completion of analysis lab shall submit report (results- scan copy by email) along with raw data through courier or field representative to company. In company, data reviewer checks the outside lab report and done the sign and date. 5.11.6 The contract laboratory should be audited by QA Head and QC Head once in every 8.0 ABBREVIATIONS QA – Quality Assurance QC – Quality control GLP – Good laboratory practices CAPA – Corrective and preventive action NLT – Not less than |
