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Geneva, Switzerland, WHO, 2006.  p. (WHO/FCH/CAH/06.1)This document is updating an earlier document (WHO/CDD/SER/85.8), and provides information on the manufacture of the new ORS that, since 2003, is recommended by WHO and UNICEF. It has been prepared to assist national authorities in establishing the local manufacture of a product of pharmaceutical quality, in order that they may become self-reliant in meeting the needs of their national diarrhoeal diseases control activities. It is emphasized that the methods recommended in the document are meant to serve as guidelines, and that they need to be adapted to meet local requirements and conditions, provided they follow the principles of Good Manufacturing Practices for pharmaceutical products (WHO Technical Report Series, No 908, 2003) that can be found in the annexes of this document. Specific information on "Quality Management", "Personnel", "Validation" and "Qualification" can be found in this annex. (excerpt)
Food and Nutrition Bulletin. 1998 Sep; 19(3):240-250.The purpose of this study was to assess the effect of humidity and packaging materials on the stability of iodine in typical salt samples from countries with tropical and subtropical climates, under controlled climatic conditions. Initially we examined eight samples. In the second phase we expanded the study to salts from 18 sources and attempted to correlate the observed stability with salt impurities naturally present in these samples. High humidity resulted in rapid loss of iodine from salt iodized with potassium iodate, ranging from 30% to 98% of the original iodine content. Solid low-density polyethylene packaging protected the iodine to a great extent. High losses were observed from woven high-density polyethylene bags, which are often the packaging material of choice in tropical countries. Impurities that provided moisture at the salt surface had the most deleterious effect. Although clear correlations were not obtained, the presence of reducing agents, hygroscopic compounds of magnesium, and so forth seemed to have the most adverse effects on the stability of iodine. Surprisingly, carbonates had little effect on stability over the range present in the samples. Packaging salt in low-density polyethylene bags, which provided a good moisture barrier, significantly reduced iodine losses, and in most cases the iodine content remained relatively stable for six months to a year. The findings from this study indicate that iodine can be highly unstable, and in order to ensure the effectiveness of local salt-iodization programmes, countries should determine iodine losses from local iodized salt under local conditions of production, climate, packaging, and storage. (author's)
[Interministerial Order No. 232 MSPS/MEFCP of 16 September 1991 relating to the quality control of imported condoms distributed in Ivory Coast] Arrete interministerial No. 232 MSPS/MEFCP du 16 septembre 1991 relatif au controle qualitatif des preservatifs importes et distribues en Cote d'Ivoire.
JOURNAL OFFICIEL DE LA REPUBLIQUE DE COTE D'IVOIRE. 1991 Sep 26; (39):633.Interministerial decree number 232 of September 16, 1991, states that condoms or lots of condoms sold or distributed in the Ivory Coast must undergo preliminary quality control testing. The testing must be done in an independent laboratory approved by the World Health Organization or the Ministry of Public Health. The laboratory tests are to be interpreted according to the annexed specifications, conforming to Ivory Coast norms. The tests and controls concern packaging and labeling, the water and pneumatic inflation tests, tests of the integrity and watertightness of the packaging, and measures of length, diameter, and thickness. The exterior and interior packaging should meet World Health Organization specifications and must indicate the brand name, the lot number, the name and address of the manufacturer, country of origin, dates of manufacture and expiration, and the size of the product. Quality control tests are required every six months for stored lots of more than 10,000 condoms. The average sample for testing is 500 units for a lot of 35,000 to 150,000 condoms and 150 units for smaller lots. The National Public Health laboratory is the reference laboratory for quality control of condoms in the Ivory Coast. Other laboratories may be approved by the Minister of Public Health.
BOLETIN OFICIAL DEL ESTADO. 1991 Nov 29; (286):8102-13.Spain's royal decree 1688/1991 of November 22, 1991, establishes technical standards for condoms marketed in Spain and declares their approval obligatory. The technical specifications for characteristics and testing methods for condoms were defined in norm UNE 53-625-89, whose previously voluntary observation was declared obligatory by the 1991 decree. The specifications of UNE 53-625-89 are presented as an annex. The decree outlines the requirements and procedures for approval, to be granted by the General Office of Pharmacy and Health Products in accordance with the criteria spelled out in this decree. Packaging and product information requirements, regulations governing inspection, marketing, and advertising, and infractions and their sanctions are addressed as well. A form for requesting approval is included.
BULLETIN OF THE WORLD HEALTH ORGANIZATION. 1998; 76 Suppl 1:9-19.Except for the artemisinin derivatives recently deployed in southeast Asia, resistance has emerged to all antimalarial drugs. The Task Force for Improved Use of Antimalarials was created within the UNDP/World Bank/WHO Special Program for Research and Training in Tropical Diseases (TDR) in 1993, with the purpose of establishing, through research, measures to take to protect the few existing antimalarials in the southeast Asian region. Research was conducted in China, Myanmar, Cambodia, Thailand, Laos, and Viet Nam. The task force characterized the problems in drug compliance in southeast Asia, and developed interventions to improve drug use in the various countries. Interventions involved drug packaging, public information campaigns, and assessments of drug quality. It was found that blister packaging worked best in improving drug compliance and that the increased cost of packaged medication did not limit its use. Poor drug quality is a major problem in unregulated countries which should be improved.
Arlington, Virginia, JSI, 1997.  p.This document includes fact sheets on the logistics associated with supplying the major modern contraceptive methods: condoms, oral contraceptives, IUDs, injectables, implants, and spermicidal/vaginal barrier methods. Described, for each method, are visual indicators of potential quality problems, recommended storage conditions, special considerations, donors/manufacturers/brands, shelf life, primary/secondary packaging presentation, units per shipping carton, and dimensions and weight of cartons. Also cited are general and method-specific references for additional information.
In: Fertility control. 2nd ed., edited by Stephen L. Corson, Richard J. Derman, Louise B. Tyrer. London, Canada, Goldin Publishers, 1994. 257-79.Correct, consistent condom use protects against pregnancy and sexually transmitted diseases (STDs), including AIDS. Condoms are an appropriate contraceptive method for any sexually active person not in a long-term monogamous relationship. Condom usage rates are highest in Japan, Scandinavia, and the UK, and lowest in Sub-Saharan Africa. The most significant producers of condoms are in the US, Japan, India, South Korea, and Malaysia. Many countries require quality testing and have standards. Two international standards exist: those of the ISO and the World Health Organization [WHO]. Requirements and tests of the WHO standard include length, width, thickness, freedom from holes, inflation, tensile strength, lubricant quantity, package seal, and colorfastness. The Condom Quality Index determines the quality of condoms in storage and is based on burst volumes. Manufacturers try to help sales by varying product design. A water-based gel is the most popular lubricant type in the US. Many manufacturers offer condoms with a spermicidal lubricant (e.g., nonoxynol-9). All common packaging materials protect against the atmosphere in temperate conditions. Polyethylene aluminum cellophane provides the best protection in developing countries. Plastic condoms and the female condom are new condoms. Contraceptive failure, breakage, and technical quality of condoms define condom effectiveness. It is difficult to compare breakage rates and efficacy of condoms against STDs and AIDS, since differences in definitions, criteria, and methodology exist. Side effects to condoms are from allergic reactions to the powders and chemicals added to the latex to increase vulcanization. Instructions for condom use should only include that information necessary to correctly put on the condom. Condoms tend to be distributed through commercial channels in developed countries. In developing countries, they are distributed through health services, the commercial sector, and community-based distribution and social marketing programs.
OUTLOOK. 1989 Mar; 7(1):9-10.Laboratory tests indicate that nonlubricated, unpackaged, latex condoms suffer rapid deterioration from direct exposure to ozone levels common in urban smog conditions. The results clearly indicate a need for careful handling of condoms during transport and storage to protect them from accelerated deterioration which can lead to breakage during use. The study was conducted with commercially available, unlubricated condoms. Treatment and control condoms came from the same packages. In the treatment group, 5 condoms were unwrapped and unrolled loosely over glass test tubes, place in a chamber and exposed to 0.27-0.28ppm of ozone (the level common in urban smog). The control group condoms were unwrapped, but left rolled up and were not exposed to zone. The treated condoms showed increased surface damage after 6-48 hours of zone damage. Damage was determined by examination of a cut edge under an electron microscope. Air burst tests revealed that the exposed condoms burst at 44% of the pressure of the untreated condoms. Condoms that are sealed in their packaging will be protected from ozone exposure; however, condoms should still be handled in a manner that will reduce their likelihood of exposure to ozone during storage and transportation.
[Unpublished] 1991 Nov.  p.The sales of Sathi brand condoms in Pakistan remained low in November 1991. In fact, a warehouse in Karachi only sold 138,240 condoms. Nonavailability of packaging material and price stickers prevented higher sales at the wholesale level. Yet the percentage of retail outlets carrying Sathi condoms climbed from 47-53% between August-September 1991. Only 11-19% of retail outlets carried other condom brands. Further only 17% of stores that sell Sathi and Durex condoms did not have Sathi condoms in stock in September compared to 18-24% of stores did not have other condoms brands in stock. Moreover the market share for Sathi condoms climbed to 69%. At the same time, the market share for the public sector brand Sultan and Durex fell from 14-10% and to 7% respectively. Rough Rider condoms held 8% of the market share. Other brands claimed 6%. A new marketing plan for Sathi revealed that PSi would hold off introducing oral contraceptives (OCs) and a premium condom. PSI and other nongovernmental organizations conducted market research of married women with 2-4 years of education to test instructions for OCs. The study indicated that they better grasped instructions when they included a lifelike pointing hand instead of an arrowhead and all arrows pointed from left to right rather than zig zag. The test marketers also improved instructions in Urdu so the women could discern other aspects of OC use. A staff member from Family Health International evaluated storage conditions of condoms in karachi and lahore. He also obtained samples of USAID procured condoms for testing in the U.S. Family planning specialists observed distribution of Sathi condoms in several villages in the Punjab and in working class areas of Lahore.
Social Science and Medicine. 1991; 32(11):1201-18.The 3 drug distributing systems in Africa, private commercial, private non-profit, and public, are described, and issues involved in improving efficiency and rational use are exposed. The private pharmacy sector in Africa is largely located in cities, with retail prices multiples of those charged for name brands in the West. It includes pharmacies, drug shops, injection rooms, and drug peddlers, who obtain their supplies from wholesale and retail sources, and frequently pilferage from public supplies. The private non-profit system, largely missing health agencies, are often well-managed by regional drug procurement associations. The public sector consists of government and para-public enterprises and their distribution facilities. Supplies are limited, especially at the end of the transport chain, because of deficit financing and logistical obstacles. It is best to employ expatriate managers who are immune to local corruption. The most effective points to improve efficiency in drug supply are in procurement: to select generic drugs, take advantage of credit for certain brands, avoid non-essential, low priority, and expired drugs. Great savings could also be obtained by sound logistics, proper storage, and avoiding local purchase of emergency supplies. Rational use of drugs can be improved by consistent, conservative prescription, kits for managed care, and for AIDS especially, management protocols. Most African countries have their own pharmaceutical production facilities, but these have lost money because of the high cost of imported raw materials, technology and personnel. These facilities could best be used to formulate or re-package generics bought in bulk for local needs, to produce intravenous fluids, and to make simple products such as ointments at a profit. It might be efficient to produce essential drugs under regional agreement and quality control, avoiding duplication. Some concerns peculiar to Africa are self-medication, "cultural re-interpretation" of Western medications by users and traditional practitioners, sparse populations without transportation infrastructure, counterfeit drugs, and an entrenched informal system of private sales of non-essential and ineffective therapeutic agents. AIDS is an added burden to an already strained health system.
[Unpublished] 1989 Mar. 5,  p.Researchers have estimated that normal condom breakage varies from .5%- 10% and deteriorated condom breakage ranked as high as 50%. These figures have prompted condom manufacturers to make condoms that meet international and national standards for leakage (<.4%). Yet condoms deteriorate when exposed to oxygen, humidity, ozone, or industrial pollutants. Family planning managers, especially those in tropical countries, must do quality monitoring of condoms in storage. they can do this by using sampling techniques that assure an adequate sample size to detect and quantify aging effects. In Indonesia and Bangladesh, burst volume tests indicated that the older the age of stored condoms the lower the amount of air required to burst them. Indeed aging reduces elasticity. Clinical studies involving repackaged condoms which were exposed to ultraviolet (UV) light for 0-10 hours in Seattle, Washington and in Indonesia showed that the risk of condom failure during used increased when burst volumes were <15 liters which compare with limits for air burst volume set by the International Organization for Standardization. Since packaging can protect condoms against environmental factors, it should be impenetrable to light, especially UV light, to radiant heat, to oxygen, and to water vapor. Further, antioxidants must be used in condom packaging. Accurate and clear instructions on consistent and correct use should accompany condoms. For example, mineral and vegetable oils directly on the latex deteriorates condoms. So packaging should instruct users not to lubricate condoms with these oils. In conclusion, researchers should conduct more stability studies on aging properties of condoms and on protection against environmental factors.
[Unpublished] 1991 May. iii, 61 p.This WHO Specifications for Latex Rubber Condoms is appropriate for photocopy as an attachment to the Invitation to Bid and Purchase Order. Section 6 provides a place to indicate size or other specifications. The standard provided is the minimum for use and storage and delivery. Procurement needs to take into account 1) quality of design, and 2) conformance to specifications. Essential criteria are uniform high strength and elasticity and the absence of holes. Chapters include: 1) reason for specification and guidelines, 2) choice of design features, 3) alternative design specifications. The specifications include: 1) scope and definitions, 2) international standards and other publications, 3) requirements for materials, construction, lubrication, tensile properties, freedom from holes, bursting volume and pressure, colorfastness, individual packages, identification marking on individual packages, workmanship, 4) quality assurance provisions for compliance, objective evidence, inspection by purchaser, sampling procedures, examinations and tests for specific properties, inspection of packaging and marking, 5) packaging for delivery (inner boxes, consumer packs, exterior shipping cartons, markings for lot traceability) 6) ordering data. The WHO guidelines for condom procurement reports on 1) testing to insure conformance to specifications, 2) qualifying condom suppliers, 3) invitation to bid, 4) purchase order, 5) predelivery quality check. Additional support documents include: 1) essential performance criteria (limiting condoms that will break during use, that may leak during use, that may deteriorate on the shelf), 2) choosing from available design options (length, width, thickness, shape, lubrication, color, packaging), 3) manufacturers list, 4) invitation to bid, 5) WHO forms: Request for offer and request for sealed bids, 6) purchase order, 7) aggregate analysis criteria for shipments or orders. The recommended condom is parallel sided, reservoir end, 49 2 mm flat width or 53 2 mm flat width, 170 to 180 mm length, .05-.08 mm single wall thickness, smooth surface, no color, translucent, silicone fluid (plain) lubricant, and packaged in square plastic-aluminum foil laminate in 100 units per inner box.
CONTRACEPTIVE TECHNOLOGY UPDATE. 1987 Apr; 8(4):52-3.Due to a packaging error that left white placebo pills in place of active pills, Gynex Inc. has had to recall 325,000 packages of generic oral contraceptives (OC), a mistake that the company insists has not affected consumers. Company vice president Stephen M. Simes says that although the majority of the defective packages remain in the possession of wholesalers and chain store warehouses, some had been shipped to pharmacies. But presently, it seems that none have reached consumers. Recently entering the generic OC market, the company's packaging error involved its first shipment of Gynex 1/35E and Gynex 0.5/35 in 28-day packs. These two generics are copy products on ON 1/35, made by Ortho Pharmaceutical, Modicon/Brevicon, made by Ortho Pharmaceutical and Syntex Laboratories--two widely used OCs. While the company is still investigating the incident, Simes explains that the company is enacting changes in the packaging procedures and is considering alterations in machinery and in quality control. The error will probably represent a financial loss for the company, and it will delay Gynex's entry into the contraceptive market. But the California-based company plans to press ahead, having already filed marketing applications for 5 additional low-dose OC formulations.
Interchangeability of low-dose oral contraceptives. Are current bioequivalent testing measures adequate to ensure therapeutic equivalency?
CONTRACEPTION. 1991 Feb; 43(2):139-47.Current Food and Drug Administration guidelines for assessing the differences in bioavailability between generic oral contraceptives (OCs) and brand name products are inadequate to ensure therapeutic equivalence. The guidelines do not take into account those women who may have blood levels of active ingredients well outside the range of acceptability. Due to the narrow therapeutic range of steroids, these women may become pregnant or experience an increased incidence of breakthrough bleeding. Furthermore, OC packaging is unique to each manufacturer, and any change in brands (and thus in packaging) can easily negate the sequential administration of the appropriate tablet. These are among the reasons suggested for placing OCs into the critical drug category, where generic substitution and interchangeability of products should not be allowed. (author's)
Seattle, Washington, PATH, 1990 Apr. v, 80,  p.A private contractor for the US Agency for International Development did a study on the provision of assistance to the private sector in developing nations for the production of contraceptives. The study has 4 objectives; to provide USAID with various strategies for meeting the demands for contraceptives in developing countries in the 1990's; to recommend activities to facilitate local private production of contraceptives; to provide an update on certain examples in the production of contraceptives in Egypt, Bangladesh, India, and Mexico; and to outline how developing countries can gain technical assistance for private sector production from US private and government agencies. Results indicate that estimated capital investments required for local production are modest. There are large scale projects in Egypt, India, and Bangladesh to initiate large scale local production of contraceptives. Most of the capital investment and operating costs can be paid in local currency. However, in countries other than Bangladesh and Egypt, there are limited opportunities for USAID to assist in the establishment of new private sector production ventures, but there are possibilities for upgrading and expanding existing facilities. Technical services provided by government and private agencies can assist developing country firms with local production of contraceptives. It was recommended that assistance be provided to initiate, upgrade, and expand local contraceptive production in selected developing countries. The transition from imported donor supplied to local production should be facilitated as well as intermediate production. Long term investment by technology suppliers should be ensured. Public-private partnerships should be included and supported. USAID should provide assistance in quality oversight capabilities, establish a clearinghouse for requests, and coordinate with other agencies. Case studies on contraceptive production in India, Bangladesh, Egypt and Mexico are presented.