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\def\citeauthor{~Sunil~Kumar,
              ~Bommireddy~Srilekha}
\def\citetitle{Good Storage and Good Distribution Practices of Pharmaceuticals in India and the USA With Regulatory Enforcement}
\def\copyrightstmt{This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial- ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.}
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\def\RunningAuthor{Sunil Kumar and Bommireddy Srilekha}
\firstPage{42}
\articleType{Review Article}
\receivedDate{20 Dec 2022}
\acceptedDate{07 Jan 2023}
\revisedDate{06 Jan 2023}
\journalVolume{3}
\journalIssue{2}
\copyrightYear{2023}
\eISSN{2583-0953}
\journalDoi{10.26452/ijcpms.v3i1.495}
\def\authorCount{2}
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\def\journalTitle{International Journal of Clinical Pharmacokinetics and Medical Sciences}

\title{Good Storage and Good Distribution Practices of Pharmaceuticals in India and the USA With Regulatory Enforcement}
\author{Sunil~Kumar\textsuperscript{*}\textsuperscript{1}, 
            Bommireddy~Srilekha\textsuperscript{2}~\\[5pt]{\textsuperscript{1}Department of Pharmaceutics and DRA, Sun Institute of Pharmaceutical Education and Research, Kakupalli, Nellore, Andhra Pradesh, India}~\\{\textsuperscript{2}Sun Institute of Pharmaceutical Education and Research, Kakupalli, Nellore, Andhra Pradesh, India}}

\begin{abstract}
The distribution of pharmaceutical products is critical to the success of an integrated supply chain management system. It is essential that the concepts of Good Distribution Practices (GDP) and Good Storage Practices (GSP) are followed in all aspects of pharmaceutical product distribution and storage operations. Due to the fact that they are both components of the pharmaceutical product management chain and, as such, are closely related, the terms GSP and GDP are sometimes used interchangeably.
\end{abstract}\def\keywordstitle{Keywords}

\begin{keywords}Pharmaceuticals,\newline USA,\newline Regulatory Enforcement
\end{keywords}
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\makeatletter{\raggedright{\Large$^\ast$}Corresponding Author\par Name:\ Sunil~Kumar~\\ Phone:\ 8185090965~\\  Email:\ sunil.kandukuru@gmail.com
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        \makeatother
        
    
\section{Introduction}
The distribution of pharmaceutical products is critical to the success of an integrated supply chain management system. Good Distribution Practices (GDP) and Good Storage Practices (GSP) must be followed in all aspects of pharmaceutical product distribution and storage operations. Because they are both components of the pharmaceutical product management chain and, as such, are closely related, the terms GSP and GDP are sometimes used interchangeably. Wholesale distributors must adhere to Good Distribution Practices to safeguard the quality and integrity of drugs along the supply chain. Good Storage Practices is a word used in quality assurance to describe the procedures and methods used to ensure that a pharmaceutical product's quality is maintained throughout its Storage \unskip~\cite{2028535:28690819}.

Pharmacovigilance-related businesses, organizations, and institutions all have vital roles to play in pharmacovigilance. Medications' potency and physical integrity will be preserved and maintained if they are kept in an appropriate environment. It is expected that the storage conditions from materials and commodities will be in compliance with the product labelling and that they will also prevent deterioration.\ensuremath{^{}} GDP principles should be incorporated into national legislation and standards to protect the integrity of the supply chain from Manufacturer to dispensing organization. Collaboration between regulators, law enforcement, customs agencies, pharmaceutical makers, dealers, and pharmacies is required to move medications forward and backward in the distribution chain [Figure~\ref{f-cef502ef99bb}] \unskip~\cite{2028535:28690817}.

This part of the study begins by focusing on improper Storage at various storage points by way of distribution from the manufacturing premises to the patient shelf, which may affect the stability of the products.  In the simple models popular with industry analysts, the Indian drug distribution system has a small number of layers. The possible storage areas for the pharmaceuticals are detailed below.


  
  \begin{enumerate}
  \item \relax Warehouse in the manufacturing premises
  \item \relax Clearing and forwarding agents
  \item \relax Government warehouse
  \item \relax Wholesalers
  \item \relax Hospital/Nursing homes
  \item \relax Retail/Chemist stores
  \item \relax Patient's storage/cabinet
  \end{enumerate}
  The pharmaceutical products are stocked at the following storage points listed above.

\textbf{Warehouse in the manufacturing premises }

Room temperatures in the warehouse at pharmaceutical manufacturing units are not frequently/ adequately monitored; in summer, the temperature in the room may exceed 30\ensuremath{^{\ensuremath{^\circ}}}C. Some of the warehouses possess metal as best sheets as roofing. Air conditioning is also provided only in a separate area where drugs that require being stored in a relaxed environment are stocked. Formulations with Ampicillin,  Cephalexin, Erythromycin, Gentamycin, Tetracycline, etc. Only in some warehouses are generators provided in case of power failure \unskip~\cite{2028535:28690823}  [Figures~\ref{f-038ca54a2868} and~\ref{f-30d4205b2074}]. 

\textbf{Clearing and forwarding agents}

Primary pharmaceutical distributors purchase prescription medicines and other medical products directly from manufacturers and store them in warehouses and distribution centres. Healthcare providers order the medications and items packaged and shipped daily from manufacturers [Figures~\ref{f-4396d6300df2} and~\ref{f-ed690b7075c0}].

It is observed that the temperature is not monitored for drugs at the C\&F level, so necessary corrections are not adopted to maintain a uniform temperature [Figure~\ref{f-926eb9bd795c}].

The Government warehouse's storage facilities are not different from other warehouses. The various storage conditions required are usually not provided in the warehouse.

\textbf{Wholesalers}

Wholesalers usually store the consignment in storage areas without proper light, ventilation, and temperature control. These pictures depict how they stack the pharmaceuticals due to different constraints and issues \unskip~\cite{2028535:28690829}.

\textbf{Hospitals/ Nursing Homes}

One of the few places where the Storage of pharmaceuticals is commendable is Hospitals and Nursing. Generally, all medications are appropriately stored/ stacked in racks for easy identification and quick retrieval. In addition, the drugs which require cold Storage are refrigerated, and most of the drugs are stored in a controlled environment \unskip~\cite{2028535:28690821,2028535:28707591}  [Figure~\ref{f-705eac17eb1f}].

\textbf{Retail/ Chemist outlets}

Retail Chemist shops are distributed throughout the country in all the temperature zones from Hot and Dry Areas, Hot and Humid areas, Highly Humid areas, Coastal regions, High Rainfall areas, etc. Rule 64 of Drugs and Cosmetics Rules, Condition to be fulfilled before a license in (Form 20, 21, 20-F, 20-G, 20-B, 21-B) is granted/renewed, specifies that the area for Retail license should be not less than 10 square meters. For wholesale support, the site should be not less than 10 square meters. If permission is sought, the site should be not less than 15 square meters. The retailer wholesale premises with this dimension may have an RCCR offing or a Sheet with false roofing. During summer, in the Hot and Dry zones, the temperature may rise to above 30\ensuremath{^{\ensuremath{^\circ}}}C. Drugs stored at this temperature for more extended may lose their potency order grade chemically \unskip~\cite{2028535:28690818,2028535:28690820} .

Thousands of formulations are stocked in retail or wholesale premises with no control over temperature or protection from light and humid environments. This is the prime area of concern since the pharmaceuticals are stored long in abnormal temperatures and humidity, which can adversely affect the drug products [Figure~\ref{f-ea36629d5b5e}].

Several studies were conducted to see how storage conditions affected the potency and efficacy of stored formulations. The following are the study's specifics: Studies have shown that improper Storage of Drugs at retail stores reduces drug potency. Drugs in India lose 3-4 \% of their strength at Chemist's shops because they are not stored correctly, as indicated by the results of a recent study.

The year-long study by the Delhi Pharmaceutical Trust, or DPT, a body of pharmaceutical scientists and senior pharmacists, shows that degradation occurs in medicines before they reach the expiry dates (printed on the label) due to uncontrolled  temperature, exposure to light and moisture, and, among other things, when they are transported from the manufacturing site to retail points and retail shops. The focus was on selected brands of four drugs; cephalexin, ranitidine, rifampicin, and the ampicillin-cloxacillin combination, manufactured by reputed drug makers. The trust has made recommendations to the Indian Pharmacopoeial Commission, which brings out the drug standards that indicate the quality and efficacy  of drugs in India, alerting it to the need to change the pharmacopoeia's general chapters regarding drug storage. The survey was conducted to scientifically capture the variations in temperature and humidity levels observed at various chemist outlets in New Delhi and investigate the real-time effect of pharmaceutical product storage and stability.  The drugs have shown different levels of degradation in potency, far higher than the permissible limit, at the outlets that did not maintain specified temperature, light, or humidity levels. Since these products are made by only big and reputed firms, which generally ensure proper drug stability while manufacturing and packing, degradation in drugs manufactured by small companies could be much more significant. Currently, there are no codified norms in India on storage practices, though guidelines in the pharmacopoeia, such as GSP and GPP, talk about temperature, moisture, and light-controlled storage requirements in warehouses and Chemist outlets. In 2003, R.A. Mashelkar, former General Director at the Council of Industrial and Scientific Research, proposed the incorporation of the Drugs and Cosmetics Act into this directive to a scientific committee on pharmaceutical quality. This would require wholesale and retail storage regulations, but the administration refused to implement them due to strong opposition from traders who were afraid of higher costs.


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\centering \makeatletter\IfFileExists{images/2a99e358-927b-4173-975c-a6ed2c7efba7-upicture3.png}{\includegraphics{images/2a99e358-927b-4173-975c-a6ed2c7efba7-upicture3.png}}{\includegraphics{2a99e358-927b-4173-975c-a6ed2c7efba7-upicture3.png}}
\makeatother 
\caption{\boldmath {Storage conditions and the life cycle of the drugs detailed within the schedule}}
\label{f-30d4205b2074}
\end{figure*}
\egroup

\bgroup
\fixFloatSize{images/a16e3ff8-6cbd-48ff-b1b6-4a6d7393f49b-upicture4.png}
\begin{figure*}[!htbp]
\centering \makeatletter\IfFileExists{images/a16e3ff8-6cbd-48ff-b1b6-4a6d7393f49b-upicture4.png}{\includegraphics{images/a16e3ff8-6cbd-48ff-b1b6-4a6d7393f49b-upicture4.png}}{\includegraphics{a16e3ff8-6cbd-48ff-b1b6-4a6d7393f49b-upicture4.png}}
\makeatother 
\caption{\boldmath {Storage of pharmaceuticals in C \& F agents}}
\label{f-4396d6300df2}
\end{figure*}
\egroup

\bgroup
\fixFloatSize{images/aed5b28d-c484-44fb-9cf1-840911f65795-upicture5.png}
\begin{figure*}[!htbp]
\centering \makeatletter\IfFileExists{images/aed5b28d-c484-44fb-9cf1-840911f65795-upicture5.png}{\includegraphics{images/aed5b28d-c484-44fb-9cf1-840911f65795-upicture5.png}}{\includegraphics{aed5b28d-c484-44fb-9cf1-840911f65795-upicture5.png}}
\makeatother 
\caption{\boldmath {Storage of finished products in C \& F agents (Air conditioned for Storage of certain drugs)}}
\label{f-ed690b7075c0}
\end{figure*}
\egroup

\bgroup
\fixFloatSize{images/7e6fe57b-13d9-421b-8443-61b6c9d7b961-upicture6.png}
\begin{figure*}[!htbp]
\centering \makeatletter\IfFileExists{images/7e6fe57b-13d9-421b-8443-61b6c9d7b961-upicture6.png}{\includegraphics{images/7e6fe57b-13d9-421b-8443-61b6c9d7b961-upicture6.png}}{\includegraphics{7e6fe57b-13d9-421b-8443-61b6c9d7b961-upicture6.png}}
\makeatother 
\caption{\boldmath {Government Warehouse facility for Storage of} Finished products}
\label{f-926eb9bd795c}
\end{figure*}
\egroup

\bgroup
\fixFloatSize{images/1e6bd5ec-cf56-4b64-8fe6-7519783a1d48-upicture7.png}
\begin{figure*}[!htbp]
\centering \makeatletter\IfFileExists{images/1e6bd5ec-cf56-4b64-8fe6-7519783a1d48-upicture7.png}{\includegraphics{images/1e6bd5ec-cf56-4b64-8fe6-7519783a1d48-upicture7.png}}{\includegraphics{1e6bd5ec-cf56-4b64-8fe6-7519783a1d48-upicture7.png}}
\makeatother 
\caption{\boldmath {View of Hospital/ nursing home pharmacy}}
\label{f-705eac17eb1f}
\end{figure*}
\egroup

\bgroup
\fixFloatSize{images/b192e8ba-8875-4418-9d30-54aa1cd80f31-upicture8.png}
\begin{figure*}[!htbp]
\centering \makeatletter\IfFileExists{images/b192e8ba-8875-4418-9d30-54aa1cd80f31-upicture8.png}{\includegraphics{images/b192e8ba-8875-4418-9d30-54aa1cd80f31-upicture8.png}}{\includegraphics{b192e8ba-8875-4418-9d30-54aa1cd80f31-upicture8.png}}
\makeatother 
\caption{\boldmath {View of drug storage in Retail pharmacy store}}
\label{f-ea36629d5b5e}
\end{figure*}
\egroup

\bgroup
\fixFloatSize{images/76a45de8-5161-4658-ab46-e15324994aba-upicture9.png}
\begin{figure*}[!htbp]
\centering \makeatletter\IfFileExists{images/76a45de8-5161-4658-ab46-e15324994aba-upicture9.png}{\includegraphics{images/76a45de8-5161-4658-ab46-e15324994aba-upicture9.png}}{\includegraphics{76a45de8-5161-4658-ab46-e15324994aba-upicture9.png}}
\makeatother 
\caption{\boldmath {Drug cabinet/shelf at home}}
\label{f-b6ce03ebee21}
\end{figure*}
\egroup

\bgroup
\fixFloatSize{images/c977a93d-aae2-4a84-a3c9-b29cb4da2285-upicture10.png}
\begin{figure*}[!htbp]
\centering \makeatletter\IfFileExists{images/c977a93d-aae2-4a84-a3c9-b29cb4da2285-upicture10.png}{\includegraphics{images/c977a93d-aae2-4a84-a3c9-b29cb4da2285-upicture10.png}}{\includegraphics{c977a93d-aae2-4a84-a3c9-b29cb4da2285-upicture10.png}}
\makeatother 
\caption{\boldmath {Life cycle Duration of drugs (a few examples)}}
\label{f-c9dfb9f1cfea}
\end{figure*}
\egroup

\bgroup
\fixFloatSize{images/adc22a88-e5fd-480e-a019-8ba4fc7a9d11-upicture11.png}
\begin{figure*}[!htbp]
\centering \makeatletter\IfFileExists{images/adc22a88-e5fd-480e-a019-8ba4fc7a9d11-upicture11.png}{\includegraphics{images/adc22a88-e5fd-480e-a019-8ba4fc7a9d11-upicture11.png}}{\includegraphics{adc22a88-e5fd-480e-a019-8ba4fc7a9d11-upicture11.png}}
\makeatother 
\caption{\boldmath {Storage shelves for pharmaceuticals in a modern pharmacy}}
\label{f-f156543adf8f}
\end{figure*}
\egroup

\bgroup
\fixFloatSize{images/eefa6bad-fd20-4125-ac90-3e9f7e1a991b-upicture12.png}
\begin{figure*}[!htbp]
\centering \makeatletter\IfFileExists{images/eefa6bad-fd20-4125-ac90-3e9f7e1a991b-upicture12.png}{\includegraphics{images/eefa6bad-fd20-4125-ac90-3e9f7e1a991b-upicture12.png}}{\includegraphics{eefa6bad-fd20-4125-ac90-3e9f7e1a991b-upicture12.png}}
\makeatother 
\caption{\boldmath {Storage conditions and labelling statements in the US}}
\label{f-631caf6d2d3e}
\end{figure*}
\egroup

\bgroup
\fixFloatSize{images/e72f81a7-8fe2-4df4-b3e3-a8be998c9479-upicture13.png}
\begin{figure*}[!htbp]
\centering \makeatletter\IfFileExists{images/e72f81a7-8fe2-4df4-b3e3-a8be998c9479-upicture13.png}{\includegraphics{images/e72f81a7-8fe2-4df4-b3e3-a8be998c9479-upicture13.png}}{\includegraphics{e72f81a7-8fe2-4df4-b3e3-a8be998c9479-upicture13.png}}
\makeatother 
\caption{\boldmath {Comparative Regulatory Guidelines for Distribution of Pharmaceuticals}}
\label{f-d9d7295fef8c}
\end{figure*}
\egroup
A 2007 order from the central drug regulator to state food and drug authorities, asking them to enforce air conditioning in all drug outlets, also faced strong protests from the wholesale and retail traders.

Though most retail outlets in cities and towns use one or two refrigerators to keep drugs such as vaccines and injections that bear a tag of below 20\ensuremath{^{o}}C temperature, it is not often followed by many. Also, such arrangements may not bead equate to storing all such packs. Chemist outlets tend to avoid storage specifications because of high electricity costs.  A study was also carried out to see how temperature affects insulin's potency and pharmacological action. Thermolabile drugs and vaccines are known to lose their strength if not kept at controlled temperatures. Insulin is a labile medicine sensitive to extreme sunlight and temperatures that must be kept chilled between 2 to 8\ensuremath{^\circ} C. Insulin, according to previous studies, is degraded by hydrolytic reactions or converted into higher molecular clin vials should be kept cooled to 2\ensuremath{^\circ}C to 8\ensuremath{^\circ}C and kept away from light if not in use. The study aimed to see if wrong weather storage time impacted the strength of the three formulations evaluated for insulin since proper handling is needed to perform the insulin.

\textbf{Patient's home}

A hot, humid environment can speed up the breakdown of drugs and kill their potency. Chennai, especially during summer, is anything but a cool, dry place, and your drug might end up doing the opposite of what they are expected to do. Experts say antibiotics and biological medicines stored at home during summer also the season of power cuts {\textendash} are most prone to damage. For most Indians, the popular spots for storing medicines are kitchen or bathroom cabinets, which are the worst storage areas as the places are exposed to heat and humidity\unskip~\cite{2028535:28690831,2028535:28690826}  [Figure~\ref{f-b6ce03ebee21}].

Every formulation is prescribed specific storage conditions by the Indian Pharmacopoeia, the sole authority for all drugs manufactured and sold in India. The medicine may become inert before its expiration date if it is not followed.

The potency period of drugs about storage conditions specified by the Indian Pharmacopoeia is dealt with in Schedule P of the Drugs and Cosmetic Rules. People who store medicines at home stack them carelessly, whereas trained pharmacists follow the storage protocol. Some patients, especially elderly persons living alone, buy large quantities of medicines to avoid frequent pharmacies. Most antibiotics and biological drugs get spoilt if not stored under specified conditions for a prolonged period, say, for over a month," said an expert from the pharmaceutical industry. Insulin, for example, should be stored in a refrigerator, at 2-8\ensuremath{^\circ}C. "Insulin loses its potency if not stored properly, and it will not be able to reduce sugar levels. Several families hold over-the-counter drugs at home. I~always keep some standard tablets and cough syrups at home. In fact, I~keep the syrups in my kitchen.

Making things worse are the power cuts. Madhava Naidu, a resident of Vadapalani who had suffered seizures, said he got flustered every time there was an outage. I~have a separate mini-refrigerator to store my medicines.  But when there is no power for hours, there is little that you can do, he said.  Aspirin tablets, for example, can break down into acetic acid (vinegar) and salicylic acid in a hot environment (kitchen cabinet, card ash board), causing stomach irritation. Ampicillin, Amoxicillin, Cephalexin, Chloramphenicol, Cloxacillin, Doxycycline, Erythromycin, Rifampicin, all Penicillin drugs, Tetracycline, and Gentamycin, are some of the common medicines that must be stored at room temperature (25degreesCelsius). These are antibiotics that are commonly used.  Vaccines must be kept in a cooler at 2-8\ensuremath{^\circ}C. The temperature  inside a non {\textendash} AC room in Chennai can touch 32\ensuremath{^\circ}C.  Oral antibiotics are usually marketed as dry powders that must be reconstituted. To get the most out of the drug, several reconstituted antibiotic suspensions should be held cooled. But for a variety of reasons, a lack of refrigeration or in stable power supply, which leads to a variance in the degree of product deterioration, many patients don't adhere to the storage conditions specified. As a result, pharmacists have to warn patients if refrigeration or intermittent control is insufficient for cooling. 

This study has examined the stability of the potassium suspension by amoxicillin-clavulanate under simulated domestic unpredictable power and cooling conditions. 

Amoxicillin-clavulanate suspensions were replenished  and processed in three various home storage conditions at temperatures of 5{\textendash}29\ensuremath{^\circ}C for 10 days. For the study of suspension samples, a validated HPLC approach was used. 

The concentrations of potassium amoxicillin-clavulanate were greater than 90\% until the fifth day. Still, depletion by 70 days and concentrations of amoxicillin dropped below  80\% under two circumstances, and concentrations of clavulanate fell below 70\% under all three conditions. 

A healthy 5-day at room temperature (27-29\ensuremath{^\circ}C) reconstituting amoxicillin-clavulanate potassium; discourages reconstitution of the suspension which has not cooled adequately after the fifth day.

From the above studies conducted, it is obvious that degradation occurs in medicines in medicines much before their expiry date printed on the label due to uncontrolled temperature, exposure to light, and moisture. 

This is because of improper  Storage at various levels of storage points and during the transportation from the Manufacturer to the retailer [Figure~\ref{f-c9dfb9f1cfea}].

\textbf{Ware House Storage of Pharmaceuticals}


  
  \begin{enumerate}
  \item \relax Storage places must be preserved/built to meet good storage practices.
  \item \relax Storage areas must be well protected, sound structurally, and sufficiently wide for safe Storage and handling.
  \item \relax Sufficient lighting is needed in storage areas to ensure accurate and secure operation.
  \item \relax Cautions must be taken to avoid the entry into storage areas of unauthorized people.
  \item \relax Quarantined biological products, released, discharged, sent, goods as well as alleged spurious, must remain in separate areas.
  \item \relax Storage areas shall be clean, dry, and maintained within a reasonable temperature, built or adapted to guarantee adequate and suitable conditions of Storage. Biological products must be held off the ground and correctly spaced to allow cleaning and inspection. Clean and in good condition, pallets must always be preserved.
  \item \relax Regular cleaning of buildings and storage areas is required.
  \item \relax A written pest control policy must also be developed, and the pest control agents used must be safe without the risk of contaminating biological products. Adequate clean-up protocols must be designed to ensure that any chance of pollution is removed.
  \item \relax Contamination and contamination must be prevented if the sampling is performed in the storage room. Sampling areas must be cleaned up procedures.
  \item \relax The receiving and dispatch bays must be protected from the elements since they contain biological materials. Receipt areas must be constructed and equipped so that incoming organic containers are cleaned before being stored, if at all possible.
  \item \relax Organic goods must be treated and processed to ensure that deprivation, mixing, and cross-infection are prevented. A scheme must be in place to ensure the first sale and/or distribution of biological products expires (FEFO). There may be exceptions if required, given that appropriate regulations are in place to avoid  the sale of products which have passed.
  \item \relax Plan to remove broken or damaged goods and store them separately from unusable supplies \unskip~\cite{2028535:28690830}.
  \end{enumerate}
  \textbf{Pharmaceutical Storage in Retail Pharmacies }

The Storage of drugs is among the most essential tasks of pharmacists. Consequently, adequate procedures must be developed to ensure compliance with these obligations. The medications must be handled as accurately as possible so they do not get  contaminated and decay. The product's stability is beyond the context of processing and use. The effects of air, humidity, light, and heat must be carefully considered. One of the main problems of medical care is the treatment of pharmaceutical drugs. The conditions of production and  Storage of pharmaceutical products can significantly affect their quality. The main degradation factors are relative humidity and high temperature (RH). Several factors can affect a product's final quality and, thus, its stability to sell, such as temperature, humidity, air pollution, and the time it takes to make the product. A cooling plant is also used in a wide range of items that must be kept at a specific temperature and monitored at all times. An auditable and secure inventory must be maintained. All should be in good working order with light, humidity, air, temperature, and safety. In compliance with the Manufacturer's instructions and terms of product authorization, all medicinal products must be processed. In conditions suitable for the product's quality and stability, the pharmaceutical stock should be processed. Defending against pollution, UV radiation, dampness, and extreme temperatures should be given priority. It is best to keep medicines in their original packaging when storing them. All instances in which drugs are processed during delivery must adhere to proper handling rules \unskip~\cite{2028535:28690828}.

Pharmaceutical items should be packaged in a hermetically sealed container to avoid contamination  by foreign materials, liquids, or vapours and product loss under typical handling and storage conditions. For proper Storage, the following considerations should be taken:


  
  \begin{enumerate}
  \item \relax Cleanliness
  \item \relax Ambient temperature
  \item \relax Brightness
  \item \relax Humidity
  \item \relax Proper ventilation
  \item \relax Segregation
  \end{enumerate}
  \textbf{LABEL STORAGE CONDITION}

In compliance with labelling, pharmaceuticals, and materials centred on the findings of stability analysis shall be processed. It is necessary to specify and explain the product storage conditions on the label. According to label directions, all drugs should be processed. When indicated in the mark, a check should be carried out for humidity,  light, and other factors. Storing is as it should be built or modified to ensure suitable storing environments. Specific storing conditions must be indicated on the brand of the product. Written instructions should be accessible to out-of-label storage situations specifying what to do during temperature excursions. Any departures from the labelled storage conditions shall be thoroughly investigated, and the stock in question shall be disposed of using proof (for example, stability data and technical justification). Stability tests determine the consistency of the medicinal matter or product, allowing for the prediction of shelf life, the establishment of proper storage settings, and the provision of labelling requirements, all of which are affected by environmental influences \unskip~\cite{2028535:28690825}.

\textbf{United States of America (USA) }

It describes how to preserve the integrity of preparation, including its appearance, in the correct storage environment before it reaches the customer. The marking of most items shows the conditions for Storage. Articles of pharmacopoeia shall be stored at locations that satisfy the specification of the Manufacturer  \unskip~\cite{2028535:28690827}.

\textbf{Warehouses}

To create a helpful temperature profile that includes temperature changes and conditions in different areas of the warehouse, it is essential to track temperature variations in a warehouse over time. These findings have details and knowledge on the positions of stocking and Storage of various items.

\textbf{Temperature Profiles Establishment}

The required amount of thermometers or other temperature recording devices may be used to develop temperature profiles. The warehouse should be split into parts, and maximum and minimum temperatures should be registered in 3 consecutive cycles of 24 hours. In the temperature profiling process, the following variables are to be considered, some of which may cause extreme temperatures: room size, the position of space warmers, sun-facing walls, low ceilings or towers, and the geographical location of the warehouse.

\textbf{Labelling, Storage, and stability}

In the design of stability studies for pharmacopoeia articles, the conduct, characteristics, and stability of the medication product, as well as the knowledge from clinical formulation studies. To cover the store, shipping, delivery, and subsequent use, the study duration and storage conditions in a Pharmacopeia paper should be enough. The ICH effects of quick testing in an intermediate environment can be utilized to determine the impact of brief excursions outside label storage settings, for example, during delivery.

Storage statements should be based on stability assessments of pharmacopeial drug substances and must comply with applicable national and international standards [Figure~\ref{f-f156543adf8f}].

Pharmaceutical companies consider various factors when developing medications, including the most effective dose, side effects, the method of administration (oral, injection, transdermal etc.), and the results of overdosing, safety, and efficacy. Understanding the impact of Storage on the preparation takes a significant amount of  time. These tests will determine whether the medication is stable at room temperature, requires refrigeration, or must be frozen, as well as any degradation during Storage. We'll gonna journey to see how this applies to pharmacies. Suppose no condition of Storage of prescription medicine is set. In that case, the medication may, as specified in the official compendium, be stored at the "regulated" room temperature to  ensure the identification, potency, efficiency, and purity of the product are not affected. Adequate manual, electromechanical or electronic humidity and temperature monitoring instruments or logs should be used to record the proper Storage of prescription medicines.

\textbf{For all stored drugs, the record-keeping requirements must be followed:}

Any organization must identify its storage locations to ensure adequate controls are in place. Examples of such sites include warehouses, stock-housing or holding areas, original warehouses of suppliers, warehouses of contractors, wholesale  distribution stores, postal or retail pharmacy storage areas, hospital storage areas, and border storage areas of customs. Two fundamental processes will take place in these areas. Accepting a prescription product into a facility is to be obtained for Storage, while transfer means transferring a drug product within  or from a facility. Second, the storage and servicing phase in the supply chain refers to the temporary ownership of a drug product during which no effect is transferred.

\textbf{Buildings and Facilities Storage:}

The drug product storage temperature shall be kept within the product label-defined limits. Construction and structures used for storing, storing, and/or holding drug products should be reasonably large for the intended use. These installations should  prevent overcrowding that can lead to pollution. The building and facility should be built wherever possible to monitor environmental conditions and create materials that can be easily cleaned. Procedures for sanitation and pest control, including frequency of cleaning, products used, and procedures, should be reported. If the software is used for managing storage conditions, the software must be sufficiently trained for the  mission. Tests should be installed in installations to minimize risks, including fire, water, or explosion. Certain drug products can, and should be stored as such, pose these dangers [Figures~\ref{f-631caf6d2d3e} and~\ref{f-d9d7295fef8c}].

\textbf{Storage of Pharmaceuticals in Retail Pharmacy }

\textbf{Areas for Storage}

Safety procedures for evacuating unauthorized individuals from the warehouses should be taken. Warehouse areas should be wide enough to allow for proper stocks of various materials and types of items, including startup or package materials, intermediate products, bulk and finished products, quarantined products, and products that have been launched, denied, retrieved, or retrieved. Humidity levels should be kept warm and tidy and in appropriate conditions. Specifies, monitors, and records particular storage area conditions (e.g., relative humidity, temperature) on the mark. The storage space must be clean and free from scraps and parasites, and the pallets must be maintained clearly and well-built. Stock and floor shall store materials and pharmacological articulations with adequate room for cleaning and inspection. There represents the regularity of washing and cleaning approaches in the buildings and storage zones. A written pest management strategy must also be drawn up. The controllable pesticide should be inert and not be contaminated by pharmaceuticals or products. There must be proper measures to ensure that any risk of contagion is eliminated \unskip~\cite{2028535:28690822,2028535:28690824}.

\textbf{Conditions of Storage}

In compliance with labelling, pharmaceutical products and materials based on analysis of stability testing shall be processed.

\textbf{Storage conditions are being monitored.}

The temperature control data recorded should be accessible. It is necessary to inspect the monitoring systems and to report and sustain the results in appropriate predetermined intervals. All monitoring records for at least one year should be kept or retained as material or commodities as long as existing law permits.

\textbf{Needs for Storage}

Documentation requires written orders and records.

Written instructions and documents should be available to record all operations, including how the stock has been handled in storage areas. In product recall, the methods for storing the inventory, pharmaceuticals,  and information through the organization shall be appropriately described and defined.

\textbf{Containers and labelling}

Pharmaceutical and material goods should be stored in containers that do not affect the integrity of the materials or products and provide enough protection from external influences. All containers should be appropriately marked with the drug's name, batch number, expiration date  or return date, storage conditions, and a reference to the pharmacopoeia, if applicable. Using acronyms, phrases, or codes that  have not been approved is not permitted in the workplace.

\textbf{Cold Chain / Cold Storage}

Many medicines need regulated storage and transport conditions of 2\ensuremath{^\circ}C to 8\ensuremath{^\circ}C. These medicines must be held within a small temperature range above a freezing point in the supply chain. The 'cold chain' refers to the temperature conditions under which medicines must be maintained during this period, and the Manufacturer, the shipping agent, the wholesaler, and the pharmacist must  guarantee these conditions. The four stages of a temperature mapping workout are as follows: Prepare a first phase mapping protocol. b. Complete the operation for mapping. C. Make a mapping report.

d. Implement their commendations by completing the corrective measures and other measures specified in the mapping study. To ensure successful remedial measures, a  follow-up mapping exercise may be necessary. Recommendations and Suggestions for effective implementation of Good Storage Practices and Good Distribution Practices for the required amendment under Schedule M of the Drugs and CosmeticsAct,1940, and rules there under:
    
\section{CONCLUSION}
In the present study, the regulatory status of the Storage and distribution of pharmaceuticals in India and the USA has been unveiled from available official documents. An attempt has been made to compare the regulatory status of storage and distribution practices in India and the USA. Though the regulations across the selected countries vary to a greater extent, the principles on which they are envisaged remain the same. India, a country with diversified temperatures and climates, needs practical yet implementable regulations for better Storage and distribution of pharmaceuticals. Some recommendations/suggestions have also been made to sharpen the statute and to ensure the quality and safety of medicines in India. 

\textbf{Conflict}

Nil.

\textbf{Funding}

Nil.
    
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