Common use of Batch Documentation Clause in Contracts

Batch Documentation. 12.1 BIO HOSPITAL shall document the conduct of all the procedural steps stipulated in the Master Batch record as well as all in-process controls in Batch-specific records as customarily kept by BIO HOSPITAL. BIO HOSPITAL provide OCEANA with timely notification of al significant deviations, notes to file, and other deficiencies that may reasonably be expected to impact the quality of the product, as well as copies of all FDA correspondence regarding Processing. The Quality Assurance Department of BIO HOSPITAL shall be responsible for determining Product batch suitability for approval for each batch of the Product. BIO HOSPITAL shall provide OCEANA with a complete copy of the Executed Batch Records in English. Such records shall be provided to OCEANA prior to shipment of such Batches. OCEANA Quality Assurance shall have no more than 15 business days to review the Executed Batch Records. OCEANA Quality assurance shall provide disposition of Product to BIO HOSPITAL Quality Assurance before shipment of Product can occur. OCEANA shall be responsible for the final disposition of each PRODUCT batch. The Executed Batch records must be accompanied by a Certificate of Compliance (COC) / Certificate of Release (COR) and a Certificate of Analysis (COA) for the Product. Deviation and Out of Specification (OOS) reports shall be included if applicable, which detail in writing any problems and deviations within Processing. BIO HOSPITAL shall retain the complete Batch documentation for at least one (1) year after the expiration date of the respective Batch as required by cGMP regulations, especially US federal regulation 21 CFR 211.180. BIO HOSPITAL shall provide copies of these records to OCEANA on reasonable request. BIO HOSPITAL shall notify OCEANA prior to destruction of documents and provide them to OCEANA if requested. 12.2 BIO HOSPITAL shall present Processing documentation to Regulatory Authorities upon request as appropriate and in the manner required by cGMP regulations, especially US federal regulation 21 CFR 211.180(c) and (d).

Batch Documentation. 12.1 BIO HOSPITAL shall document the conduct of all the procedural steps stipulated in the Master Batch record as well as all in-process controls in Batch-specific records as customarily kept by BIO HOSPITAL. BIO HOSPITAL provide OCEANA with timely notification of al significant deviations, notes to file, and other deficiencies that may reasonably be expected to impact the quality of the product, as well as copies of all FDA correspondence regarding Processing. The Quality Assurance Department of BIO HOSPITAL shall be responsible for determining Product batch suitability for approval for each batch of the Product. BIO HOSPITAL shall provide OCEANA with a complete copy of the Executed Batch Records in English. Such records shall be provided to OCEANA prior to shipment of such Batches. OCEANA Quality Assurance shall have no more than 15 business days to review the Executed Batch Records. OCEANA Quality assurance shall provide disposition of Product to BIO HOSPITAL Quality Assurance before shipment of Product can occur. OCEANA shall be responsible for the final disposition of each PRODUCT batch. The Executed Batch records must be accompanied by a Certificate of Compliance (COC) / Certificate of Release (COR) and a Certificate of Analysis (COA) for the - 10 - Product. Deviation and Out of Specification (OOS) reports shall be included if applicable, which detail in writing any problems and deviations within Processing. BIO HOSPITAL shall retain the complete Batch documentation for at least one (1) year after the expiration date of the respective Batch as required by cGMP regulations, especially US federal regulation 21 CFR 211.180. BIO HOSPITAL shall provide copies of these records to OCEANA on reasonable request. BIO HOSPITAL shall notify OCEANA prior to destruction of documents and provide them to OCEANA if requested. 12.2 BIO HOSPITAL shall present Processing documentation to Regulatory Authorities upon request as appropriate and in the manner required by cGMP regulations, especially US federal regulation 21 CFR 211.180(c) and (d).