Alternatives Technology Pharma Inc.

Alternatives Technology Pharma Inc.

Alternatives Technology Pharma is a services and solutions provider for Cold and Temperature Chain Management. Our products and services are integrated in global solutions and answers specific needs of the Life Sciences and Transport industries. Our solutions comply to the ICH QA (1994), WHO Good Distribution Practices, BPx, Health Canada Guidelines on temperature control for warehousing and transport of medecinal products (Guide 069), GAMP, ISO, CFR21 part 11 and the PICS part 11.

Company Details

Company Information

Jean Bedard
Title: Vice-Prsident, Directeur Gnral
Telephone: (450) 661-5966
Fax: (450) 661-7966
Email: Click Here

Products

Software And Specialised Equipment

Thermoprofile
Software and temperature data logger system that can be used as a cold chain confirmation system (transport) or in temperature distribution study in regulated environments (parmaceutical). Compliant with cGMP, 21 CFR part 11 and PIC/S chap. 11 on electronic data and signature.

Humisim
HumiSim is an environmental chamber used for the calibration and verification of relative humidity sensors.

Mirador
Solution for real time monitoring of the production and warehouse. The solution comply to all regulations in Life Sciences (BPx, CFR 21, part 11, GAMP).

Sentinel
Solution for real time cargo temperature monitoring for transport of sensitive products for the Life Sciences and Transport industries. The solution comply to the GMx, CFR21 part 11 and GAMP.

Services

Cold And Temperature Chain Compliance Services Alternatives Technology Pharma is dedicated in supplying simplicity and efficiency in Cold Chain Management through their services for life sciences, food and transport industries. We offer concrete solutions helping you reach regulatory requirements, traceability, safe production, warehousing and transportation at optimized costs. Our Technical Services can help you reach regulatory requirements relative to cold chain management, starting from raw material through to the distribution of your finished product. Based on a solid and extensive experience in sectors of production, quality control, validation and metrology for the pharmaceutical and biotechnology industries, we were able to develop regulatory logistic support for life sciences, foods, transports and insurance businesses. All our solutions and services comply with GMPs, FDA, Health Canada, EMEA, GAMP and other regulations on cold chain management. Our services will allow you to optimize your cold chain process as well as transportation costs and your compliance. COLD CHAIN ANALYSIS A complete cold chain analysis is a process that will enable you to identify all the parameters liable to influence the quality of your products. This analysis is a key phase toward optimization. The analysis begins with a complete inventory and classification of your products in order of temperature fluctuation sensitivity. It is then necessary to identify and characterize transportation axes available as well as revise and analyze existing transport contract politics and procedures used in regards to the cold chain management requirements. The analysis proceeds on through to the facilities, equipment and packaging used. Inventory and classification of sensitive products Characterization of transportation axes Facilities, equipment and packaging identification Revision of existing contract politics and procedures REGULATORY ANALYSIS The regulatory Gap Analysis will enable you to be knowledgeable about governmental requirements relative to the cold chain management in the different countries you do business with. Although the actual tendency is to standardize requirements toward a strict control of the cold chain, possessing a good knowledge of the stakes involved and tendencies will enable you to put the necessary efforts to meet requirements and help your performance during regulatory audits. The Gap Analysis compares your cold chain processes and procedures and recommends corrective actions to comply with these regulations. REGULATORY SUPPORT AND TRAINING When the need arises it will be possible for you to call on our writing services to develop politics and standard operating procedures (SOP) relative to your cold chain management. Our specialists can assist you in updating your politics and procedures or assume the entire responsibility of implementing your cold chain politics. We can also perform at your request and in your name internal quality audits for your production departments and storage facilities as well as perform external audits of transportation providers to ensure company politics and procedures are being followed. For a politic to be well established and followed it must first be well explained and understood by those concerned. We can help you with that task on an internal and external level. We also offer personalized training in our offices. OPTIMIZING THE COLD CHAIN Many parameters may influence the performance of your cold chain. It is important to identify and analyze these parameters to quantify their impact on your cold chain process. Some parameters may be altered or corrected to obtain better yield on equipment used and better conservation of products sensitive to temperature variations. Study of heat distribution in your production facilities, thermal equipment and storage Packaging optimization Transportation conditions simulations Processes and procedures optimization Packaging and transportation process validation OPTIMIZING TRANSPORTATION COSTS A large part of your handling budgets are spent on the transportation of your products from your plant to your distributors. Several approaches in optimizing these costs may be contemplated. Here are some items that should be analyzed to lower shipping and handling costs: Packaging optimization Lower the weight Lower the volume Increase conservation length through temperature monitoring to enable the use of longer and cheaper expedition services. Transportation contract revision Packaging and handling procedures optimization Replacement of non-performing equipment Let our specialists help you reduce transportation costs while ensuring the security of your sensitive products. Our services and software solutions will help you improve the quality of your products and reduce transportation costs while conforming to Canadian, American and European regulations. SOFTWARE VALIDATION Our expertise in software development and experience in validation and regulatory compliance permit us to offer you our software validation services according to the GAMP, the CFR21, part 11 and the PICS annex 11 regulations.