COLD CHAIN REGULATORY SERVICES

Alternatives Technologie Pharma is Canada’s leading provider of cold chain compliance solutions and strives to become the North-American leader- enabling Life Science partners and Healthcare organizations to assure and protect the integrity of their sensitive products and last but not least to comply with increasingly ever stringent regulations, by tracking and monitoring assets across the supply chain.

Alternatives Technologie Pharma’s significant regulatory knowledge about Health Canada, the EMA, the FDA, and particularly of Guide 069, the PDA’s Technical Report No 39, the ICH and finally the ISPE Guidelines is the result of over 10 years of enriching consultancy experience in highly regulated sectors such as biotechnological, medical, healthcare and pharmaceutical markets.

Our Cold Chain Regulatory Consulting Services include:

COLD CHAIN PROCESS ANALYSIS

The regulatory gap analysis enables the identification of specific governmental requirements relative to the cold chain management as they are applied in different countries where business is conducted. Recent trends show some standardization in increased requirements towards tighter control of the cold chain management. Knowing in advance the stakes, the implementation of current regulations requirements will result into better and positive audits, only if adequate preparation takes place to properly address specific requirements.

The risk analysis allows us to highlight critical parameters for the implementation of the cold chain management systems and solutions, and by the same token upgrading your level of regulatory compliance. This analysis is performed by constantly referring to product profile, product stability, shipment procedures, primary and secondary packaging, documentation management and component specifications, design, qualification (IQ, OQ, PQ), warehouse and storage area monitoring, personnel training, etc.

A complete cold chain analysis is the step that helps you to identify all pertinent parameters that might impact on the quality and efficacy of your products. It is a key analysis that will lead you to the step of optimization.

The first Step: Cold Chain Quality and Gap Analysis Audit.

The purpose of the cold chain and gap analysis audit, as well as its related documentation, is to verify and establish the pertinence of the cold chain regulations to the audited facility.

Verifications will be made through a close collaboration of the Logistics, Quality Assurance, Quality Control and Shipping/Receiving departments. Following its auditing, Alternatives Technologie Pharma will issues reports in which recommendations to improve the existing cold chain compliance level will be made.

Furthermore, Alternatives Technologie Pharma might suggest to establish a Master Plan that will specifically enhance the constant management and control of your cold chain compliance.

Download our documentation (pdf version) about our Regulatory Services

REGULATORY SUPPORT, DOCUMENTATION & TRAINING

Alternatives Technologie Pharma and its Engineering Services could 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 may be provided by Alternatives Technologie Pharma. 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:

Trainings should be ensured by qualified people;
Trainings 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 a specific training
for this purpose.

In this regard, Alternatives Technologie Pharma qualified experts will make sure your staff be trained on:

Cold and temperature chain management;
Good Manufacturing Practices.

Download our documentation (pdf version) about our Regulatory Services

TEMPERATURE DISTRIBUTION MAPPING SERVICES

Alternatives Technologie Pharma has the expertise and the experience to conduct your temperature mapping study wherever temperature-sensitive products are stored and handled. Usually, studied areas are:

Equipment: refrigerators, freezers, cold chambers, walk-ins, etc
Facility: Warehouses, shipping and receiving areas, including vaults, storage containers
Vehicles: Trailers, trucks, vans and containers

The purpose of the Mapping is to officially document the existing different temperature levels within several spots of a defined area where temperature-sensitive products could be stored, shipped or in-transit.

The study is performed according to a mutually agreed protocol as established by Alternatives. It is usually conducted in winter and in summer but it is recommended to be performed under all seasonal weather conditions (winter, summer and spring/fall seasons).

The temperature mapping study will highlight temperature extremes, or what is usually referred to as hot and cold spots. In order to have a full understanding of the temperature distribution, the study is performed when the studied area is empty and loaded at its full capacity. Special data loggers are spatially installed across the different areas (according to a predetermined layout drawing) and will record temperature readings every 5 minutes for a period ranging from 24 hours up to seven (7) days.

The end result is a complete and clearly documented temperature mapping report that will help you to enhance the existing storage and handling of your temperature-sensitive products, and by the same token will meet the overall objective of protecting and assuring product integrity and product efficacy.

Download our documentation (pdf version) about our Regulatory Services

TEMPERATURE PROFILE ANALYSIS

Alternatives Technologie Pharma’s expertise reflects a clear understanding and mastering of the cold chain process when gathering data on environmental hazards is at stake. Alternatives Technologie Pharma have provided manufacturers, distributors and carriers on-going environmental monitoring about factors that have influenced their cold chain system. Alternatives Technologie Pharma’s ability to identify corrective actions to drive process improvements within the cold chain process is well appreciated among manufacturers, distributors and carriers.

They are in control of their own unique cold chain routes.

Ambient Temperature Profiles of Shipping Routes:

Creating ambient profiles that realistically reflect those found in a given distribution system is an essential element in successful packaging designs and selecting distribution/logistics partners for temperature sensitive products.

Typically, at Alternatives Technologie Pharma, we conduct the ambient temperature study under two extreme weather conditions: summer and winter. Based upon your listing of shipments, a 3-week period of distribution routes is defined. Worst-case and standard destinations are selected. A pre-selection of 4 worst-case and 6 standard destinations is generally determined:

Worst-case destinations representing long haul destinations.
Standard destinations representing regular destinations.

The temperature profile study is done by using the ATP-ThermoProfile™ software platform together with data loggers Alternatives Technologie Pharma prepares the regulatory documentation, collects and analyzes the data, and issues its final report.

Alternatives Technologie Pharma will also provide you technical support should you wish to take charge of the execution of your own study. In that case, Alternatives Technologie Pharma will provide with the ATP-ThermoProfile™ system, and the training for the execution of the study.

For temperature study in distribution Alternatives Technologie Pharma is well-known for its practicality, statistically relevance, accuracy and repeatable process based on a specific distribution environment, while being 21CFR compliant.

Download our documentation (pdf version) about our regulatory Services

LABORATORY OF COLD CHAIN PACKAGING METHODS

At Alternatives Technologie Pharma, we very well understand the equilibrium role you expect from a temperature-controlled packaging:

To maintain the product temperature range
To meet all regulations,
Unfailingly safely protect your products…

…and make sure the above is being done at the lowest-possible incremental cost.

This requires expertise and precision you can expect from Alternatives Technologie Pharma. Our state-of-the–art testing Laboratory testing Laboratory and its qualified personnel is our guarantee to your success.

A First-Class Design & Testing Expertise:

Whether your needs are about testing and qualifying your existing package, or simply designing a new one, Alternatives Technologie Pharma’s test and design laboratory is the unmistakable starting point for a turn-key delivery of your cold chain packaging solutions.

At Alternatives Technologie Pharma, we temperature map your packing methods to provide you with the necessary data that will be needed to identify any variations taking place in your transportation systems. Upon request, we will also help you in performing Component Specifications (CS), Design Testing (DT), Operational Qualification (OQ) and Performance Qualification (PQ) of temperature-controlled packaging methods.

Alternatives Technologie Pharma’s expertise helps you to define and design the proper packing configuration for different temperature assurance levels: -30 to -10ºC; 1 to 10ºC; 2 to 8ºC; 15 to 25ºC or 20 to 24ºC; and and for duration periods from 12-hr to 72-hr under cold, cool or warm weather conditions (winter to summer). But most importantly it will be performed according to your own ambient temperature profiles. Our packaging methods only use prime grade insulating supply material.

Our state-of-the-art temperature-controlled conditioning equipment, environmental chambers and our ATP-ThermoProfile™ software solution makes it possible for us to develop custom-tailored testing methodologies on your behalf.

Alternatives Technologie Pharma may also supply you with its series of prequalified, portable and reusable ATP-HemoThermal™ containers (6-L up to 34-L volume capacity) to safely carry your diagnostics, drug products, biosubstances and blood products.

Download our documentation (pdf version) about our regulatory Services

VALIDATION & QUALIFICATION

Alternatives Technologie Pharma provides full qualification services, including protocol writing, protocol execution and report writing for Installation, Operational and Performance Qualifications (IQ/OQ/PQ).

The IQ/OQ/PQ protocols are written plans indicating how the qualification will be performed, including the testing parameters, the equipment characteristics and decision parameters for acceptable results. The documents include all the critical steps that have to be measured, the variability acceptable limits and the equipments testing method.

The qualification protocols are a summary of what you wishes to accomplish. All control parameters are enumerated and explanation on how the regrouped data are analyzed in order to verify their relevance. The approval by the validation team is also consigned. The qualification protocols are numbered, signed, dated, and include the following information:

Objectives, objects and contents of the qualification study;
Responsibilities, experience and team member of the qualification study;
Qualification equipment’s needed list and their normal and worst case conditions of operation and parameters;
IQ/OQ/PQ results and findings;
Calibration parameters for the qualification testing equipments;
Critical process parameters and their respective tolerances;
Process flow diagram;
Statistical tools for data analysis;
Document, graphics and matrix for data recording;
Data presentation format, conclusion documentation and qualification study’s results and reports approvals.

Download our documentation (pdf version) about our Regulatory Services