Screen reader users, click here to load entire articleThis page uses JavaScript to progressively load the article content as a user scrolls. Screen reader users, click the load entire article button to bypass dynamically loaded article content. Available online 9 July 2016In Press, Corrected Proof — Note to users Temperature excursion management: A novel approach of quality system in pharmaceutical industry Received 12 December 2015, Accepted 1 July 2016, Available online 9 July 2016Quality of pharmaceutical product largely depends upon the environment controls during its storage and handling. Each pharmaceutical product should be handled and stored under specified storage condition labelled on product information data sheet or product pack. Hence the temperature excursions during receipt of raw materials, manufacturing of pharmaceutical products and distribution should be managed during entire product life cycle with holistic approach. The research is based on primary data and exploratory study through literature review.

The temperature excursion may be observed during transportation of raw materials manufacturing as well as distribution of pharmaceutical products, which have potential to deteriorate the product quality. Temperature excursion in pharmaceutical industry should be recorded and reported to the manufacturer for further investigation and risk analysis. The concept of temperature excursions, its reasons, consequences and handling mechanism should be well understood to ensure the concerted efforts under the aegis of Quality Management System. Based on the reasons and consequences of temperature excursions during pharmaceutical operations, a system based quality management has been envisaged through this study. The concept and procedure to handle temperature excursion have evolved after this study which shall be useful to pharmaceutical industry as well as to medicine distributors and consumers.Keywords; ; ; ; 1. IntroductionThe pharmaceutical product quality largely depends upon the storage environmental conditions.

Natural reasons or human negligence could create uncalled-for situation causing temperature excursions. The most important environmental parameter having significant potential to impact quality of pharmaceutical product is temperature. If the temperature excursions are not handled systematically, there shall be an adverse impact on product quality.There is a growing need to manage the environment excursions during pharmaceutical operations and its impacts on quality of products. In an era of Quality by Design (QbD) for pharmaceutical products, the attention is paid towards inbuilt quality instead of inspected quantity (Roy et al., 2012). As manufacturers have extensive knowledge about critical product and process parameters and quality attributes, the impact assessment has to be extended to temperature excursions. The temperature and relative humidity (RH) beyond limit shall lead to product degradation rate and microbial growth. This concept is the theoretical basis for the pharmaceutical guidelines that provide recommendations for long-term, intermediate, and accelerated storage conditions and for establishing shelf life periods or expiry dates of products (Scrivens, 2012).

Pharmaceutical regulatory bodies expect strict adherence of Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) during plant manufacturing and product distribution processes. GMP and GDP are deemed as synonyms of Quality System in pharmaceutical business. Since temperature excursions are observed during raw material receipt, manufacturing operation and distribution of pharmaceutical products, there is a need of holistic approach of quality system which shall be based on both GMP and GDP.1.1. 2 ton rooftop ac unitResearch methodologyThe following instruments have been used to generate data for the study:(a)A survey has been conducted amongst pharmaceutical professionals to understand their experience regarding environmental condition during pharmaceutical manufacturing and that during distribution process.car ac repair albuquerque

The guidance papers issued by drug regulatory agencies and related literature and scientific search engines such as Google were searched for pharmaceutical supply chain risk management studies in English language. Searching through databases was done with different keywords: supply chain risk, Good Distribution Practices, Quality Risk Management, and pharmaceutical. Searching in each database was adapted to databases characteristics and additionally pharmaceutical risk. ruud central ac unitsThe result studies and meeting abstracts were screened at 4 steps and exclusion process was based on consensus of both the authors.1.2. Data and analysisThe research survey study amongst pharmaceutical professionals in India reveals that the records of environment condition (EC) monitoring during manufacturing and distribution operations follow a contrast trend (refer Chart 1). The survey alludes that deployment and monitoring of data logger results during manufacturing as per GMP are in place, whereas that during distribution operation is not so methodological.

As a part of Quality Management System (QMS), pharmaceutical industry has identified a number of core quality elements which are followed at manufacturing site level. Few of such core elements of plant quality system may be listed as,a.Documents and Record Control: There shall be good documentation practices in organization to ensure the document and online records are adequately maintained.b.Deviation Control: Incidences leading to departure from documented and approved instructions shall be recorded and evaluated for potential impact on product quality.c.Change Control: The changes to an approved design, equipment or system in pharmaceutical facility shall be adequately reviewed and validated.d.Validation Master Plan: The validation master plan shall exhibit management philosophy, strategy and commitment of organization towards validations of processes and qualification of equipment.e.Quality Risk Management: Quality risk to product shall be identified and evaluation shall be made to estimate the severity, occurrence and detectability.

A robust quality risk management.f.Training and Awareness: The organization shall develop and implement robust training programme for personnel engaged in GMP operations.g.Market Complaint Handling system: There shall be a documented procedure to receive, log and investigate each market complaint to further facilitate necessary corrective and preventive action.h.Recall Management, etc.: There shall be documented procedure to handle the recall or market returned goods.It is observed that inadequate QMS components have direct impact on consistency of storage conditions with respect to temperature and humidity. The temperature excursion is a common notion which signified the general environmental excursions (see Fig. 1).A research survey amongst pharmaceutical professionals finds that the core quality assurance aspects are followed by each manufacturing site as a part of cGMP but during distribution practices (out of plant) the above quality elements are not followed meticulously. The environmental excursion management is interlinked with Product Complaint Management, Quality Risk Management, Deviation Management and Change Control Management, sometimes as a cause or else as an effect.2.

Discussions – facets of temperature excursionQuality and environmental excursions are two important aspects of pharmaceutical operational excellence. An integrated approach for managing the quality system should include the temperature excursion management. The overall temperature excursion management can be laid down in following steps. Corrected proofs are Articles in Press that contain the authors' corrections. Final citation details, e.g., volume and/or issue number, publication year and page numbers, still need to be added and the text might change before final publication. Although corrected proofs do not have all bibliographic details available yet, they can already be cited using the year of online publication and the DOI , as follows: author(s), article title, Publication (year), DOI. Please consult the journal's reference style for the exact appearance of these elements, abbreviation of journal names and use of punctuation. When the final article is assigned to volumes/issues of the Publication, the Article in Press version will be removed and the final version will appear in the associated published volumes/issues of the Publication.