Alternatives Technologie Pharma (ATP) and our partner, TCP Reliable can develop cold chain Standardized Operations Procedures (SOPs) whenever required. Our qualified specialists may also help you to upgrade these procedures and to take charge of the implementation of all the cold chain policies.
Training on regulatory and on all aspects of the cold chain compliance requirements can be provided by ATP. Internal quality audits and mock inspections of production and storage areas may be performed. Similarly external quality audits of your preferred carrier may be undertaken making sure your cold chain policies and procedures are being followed and implemented.
According to Good Manufacturing Process Guidelines (2008 Edition):”… every lot or batch of a drug shall be fabricated, packaged/labeled, tested, and stored under the supervision of personnel who, having regard to the duties and responsibilities involved have had such technical, academic, and other training as the Director considers satisfactory in the interests of the health of the consumer or purchaser…”, furthermore:
- Training should be ensured by qualified people;
- Training should be in conformity with a written established program and training activities should be consigned in files;
- The effectiveness of the continuous training should be evaluated periodically;
- Training should be offered before any application of a new or modified SOP;
Staff working in areas where active, toxic, infectious or sensitizing products are handled, should receive specific training for this purpose;
In this regard, ATP qualified experts will make sure your staff is trained on:
- Standard Operating Procedures;
- Cold and temperature chain management;
- Good Manufacturing Practices.
