Information
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LMS Audit - Quality Control
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Plant audited
- corporate
- Montgomery, PA
- phoenix,AZ
- Kingsport, TN
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Conducted on
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Auditors
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752 Quality Control
752.1 Documentation
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Is the documentation reviewed conform ?
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Procedures: 750-PRC-0008
Instructions: -
Forms/validation: See the DMS Complete Document lIst to verify the revision of 5 documents
BRC REF: Section 3.1,3.2.1, section 3.3
752.2 Training
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Is the training up to date according to training plan ? Validate the training for 5 employees (position, GMP´s, allergens, etc.)
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Procedure: 150-PRC-0001
Instructions: 910-TRN-0001
Forms/validation: 150-FRM-0003 to 150-FRM-0018, 150-FRM-0021, 150-FRM-0057
BRC REF: 1.1.5, section 7.1, 5.2.9
753.3 non-conformities raised during the last audit are corrected adequately?
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Validate the last audit´s CAR. Are they solved? Mesures in place to prevent the situation to appen again are effective? Action plan submit for long term CAR?
752.4 Specific Procedures
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752.4.1 Raw Material and Finish Products analysis validation.
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Validate that process form and the procedure are followed -
752.4.2 Finish Product Shelf Life Validation Process<br>
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Is the work instruction followed? -
752.4.3 Calibration, validation and third party calibration of lab equipments
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Is the calibration and lab equipment maintenance Program complete ans up to date (See records for all equipments)? Are humidity and temperature verified according to the frequency establish for cooling rooms, hot rooms and storage zones? (See records) -
752.4.4 CoA Validation Process
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Validate if CoAs on the portal are initialed and have the approbaltion seal with the date
Procedure: 750-PRC-0005 section 1 and 3
Instructions: 752-INS-0001, 750-INS-0006, 750-INS-0027, 750-INS-0028, 752-INS-0008 to 752-INS-0015; 752-INS-0024; 752-INS-0031; 752-INS-0037 to 752-INS-0040; 752-INS-0051; 752-INS-0052, 752-INS-0003, 750-INS-0018, 752-INS-0006
Forms/validation : 752-FRM-0005, 752-FRM-0017 to 752-FRM-0025; 752-FRM-0041; 752-FRM-0044; 752-FRM-0046; 752-FRM-0047; 752-FRM-0056; 752-FRM-0066; 752-FRM-0069, 752-FRM-0035, 750-PRC-0004, 750-PRC-0001, 750-INS-0001, 820-INS-0001, 750-PRC-0007, 750-PRC-0003 , SAP, iPAD, 750-INS-006, 752-FRM-0010, 752-FRM-0011, 752-INS-0006
BRC REF: 3.5.2.1, 3.5.2.2, 2.14.1, 3.5.1.1, 5.5.1.1 to 5.5.1.3, 6.1.4, 3.5.2.1, 3.5.2.2, 6.3.1, section 6.1 , 6.3.2, 6.3.3, 6.3.4
Procedure:
Instruction: 752-INS-0041
Forms/ validation:
BRC REF : 5.1.4
Procedures : 750-PRC-0006
Instructions : 752-INS-0002 to 752-INS-0005; 752-INS-0007; 752-INS-0011 to 752-INS-0014; 752-INS-0017 to 752-INS-0024; 752-INS-0026 to 752-INS-0028; 752-INS-0032 to 752-INS-0036; 752-INS-0042; 752-INS-0046 to 752-INS-0050; 752-INS-0055 to 752-INS-0064; 752-INS-0067; 752-INS-0068
Forms/ validation : 752-FRM-0001 to 752-FRM-0009; 752-FRM-0012 to 752-FRM-0014; 752-FRM-0048 to 752-FRM-0055; 752-FRM-0057 to 752-FRM-0060; 752-FRM-0062 to 752-FRM-0065; 752-FRM-0070; 752-FRM-0071; 752-FRM-0073, Voir dans SAP le module de vérification des équipements (zplanpm ou IW38)
BRC REF: 5.5.2.4
Procedures : -
Instructions : 752-INS-0025
Forms/validation: -
BRC REF : -
