Research tips: to find packaging facts fast: various sources, including Web sites, journals, and books can help ease the challenges many pharmaceutical makers face when looking for data related to packaging.
In an industry as complex and regulated as pharmaceutical, locating the right packaging information is sometimes a bigger challenge than designing, sourcing, filling, or labeling the package. The good news is that the maturing of the Internet has made it much easier to find up-to-date information on virtually any packaging-related topic.
The first place to start, particularly for matters relating to regulations, guidelines, and current good manufacturing practices (CGMPs) is FDA's Web site, www.fda.gov. This Web site has a good search function as well as news, hot topics, and reference sections. The reference section is especially useful because it is divided into seven categories: laws that FDA enforces, the Code of Federal Regulations, the Federal Register, guidance documents, dockets, warning letters, and manuals and publications. The agency also offers a number of flee e-mail newsletters, and documents can be downloaded from the Web site at no charge. Studying the original regulatory documents should be a standard practice for anyone involved in packaging pharmaceutical products because regulatory information from other sources might omit important details, contain inaccuracies, and offer interpretations that are not in line with the agency's thinking.
It also should be noted that the Center for Drug Evaluation and Research (CDER) has its own home page (which can be accessed from FDA's home page by clicking on "Drugs" under the heading, "Products FDA Regulates"). It lists a number of "Quick Info" links to help find information fast.
The United States Pharmacopeial Convention Inc. (USP, Rockville, MD) provides standards for more than 3800 medicines, dietary supplements, and other healthcare products. This information is published in the USP-National Formulary (USP-NF), the official drug standards compendia. USP also provides about 1300 premier chemical Reference Standards to conduct the tests specified in USP-NF. USP also works in the area of patient safety and maintains records related to medication errors through its Medmarx database. The USP Web site, www.usp.org, offers both a search function and an on-line store where reference standards and publications can be ordered. Fees are relatively low.
Another important source for regulatory information is the United States Consumer Product Safety Commission (CPSC, Washington, DC) Web site, www.cpsc.gov, which oversees child-resistant packaging requirements. A library listing includes headings for official federal information (CPSC regulatory information) and CPSC publications. CPSC also maintains the National Electronic Injury Surveillance System, which collects data from hospital emergency rooms about consumer product-related injuries.
A wealth of domestic and global regulatory information can be found at www.packaginglaw. com, a Web site sponsored by the law firm Keller & Heckman LLP (Washington, DC). It features a different focus topic each month and archives back articles. Other sections include news headlines and an "ask an attorney" service. A search function makes it possible to check the Web site by section or in its entirety.
For topics related to parenteral products, volumes of information can be found at www.pda. org, the Web site of the Parenteral Drug Association (PDA, Bethesda, MD). The PDA Web site also has a good search function, which includes archived material. PDA is an excellent source for information about draft regulatory documents. Particularly valuable are the association's monthly newsletter, PDA Letter, and its bimonthly technical journal, PDA Journal of Pharmaceutical Science and Technology. The association also offers a Pocket Code of Federal Regulations GMP Guide--2003 Edition as well as technical reports about a variety of topics such as microbiological environmental monitoring and pharmaceutical package integrity. An on-line store simplifies ordering. Fees are nominal, especially for PDA members, who can receive a discount. Other PDA resources include a full calendar of technical meetings, courses, and audio conferences, and a well-developed network of special-interest groups, including isolation technology, packaging science, stability, sterilization/ aseptic processing, and visual inspection of parenterals. Forums provide yet another method of interaction with other industry experts.
Of course, I'd be remiss not to mention Pharmaceutical Technology's Web site, www.pharmtech.com. It archives back issues, and searches can be performed by key word, author name, or issue date. The Web site also includes a Buyers Guide to help locate suppliers as well as a list of industry links.
One of the links provided is www.ispe. org, the Web site of ISPE, The Society for Life Science Professionals (Tampa, FL). This multilingual site provides a search function as well as discussion forums and technical publications that include seminar proceedings. A resources section contains regulatory and reference areas. The regulatory area provides links to regulatory news, worldwide regulatory agencies, and regulatory documents.
Whenever you're conducting research, don't forget to check the search engines because the results can point you in new, promising directions. My favorite search engine is Google, www.google.com, but I often try more than one because the results sometimes are different. The key with Google or any other search engine is choosing the keyword or words that will generate the results you want. Usually search results are more targeted if multiple key words are used. A search for "seal integrity," for example, generates 363,000 hits with a number of pertinent references on the first page. Searching for "seal integrity stopper" or "seal integrity vial" results in a far shorter list of hits (in the 2000-4000 range) and also generates pertinent references on the first page. More importantly, the hits generated by the three-word searches are largely different from the hits listed on the first results page of the "seal integrity" search.
Of course, supplier Web sites can be essential to locating specific details about packaging materials, containers, machinery, and related items. If you don't already have a supplier list prepared, supplier directories can be helpful in locating contact information for firms you want to learn more about. Supplier directories can be found at www.pharmtech.com and on Packexpo.com's (Falls Church, VA) Web site, www.packexpo.com. The latter permits searches by either product or supplier and provides a searchable archive of news headlines and the weekly e-newsletter, Ben Miyares' Packaging Management Update. Supplier searches also can be conducted at an on-line marketplace such as www.Alibaba.com (Newark, CA), where both buyers and sellers congregate.
A number of market research firms prepare periodic reports related to pharmaceutical packaging. Freedonia (Cleveland, OH), for example, published a pharmaceutical packaging study in March 2004 and a world pharmaceutical packaging study in December 2003. Report details and ordering information may be found at www.freedoniagroup.com.
Another market research firm, Drug and Market Development Publications (Westborough, MA), www.drugandmarket.com, looks at trends and market opportunities in a March 2002 report, "Pharmaceutical Packaging--Trends Driving Innovations and Market Opportunities."
Standards organizations also provide essential information. Available in print or CD-ROM formats, Consumer and Healthcare Packaging Standards was published in May 2002 by ASTM International (West Conshohocken, PA). The 366-page book includes 85 of the latest standards on consumer and healthcare packaging, including water vapor transmission of flexible heat-sealed packages for dry products, minimum application torque of Type IA child-resistant closures, seal strength of flexible barrier materials, and detecting gross leaks in porous medical packaging by internal pressurization bubble test.
Another book published in 2002 by Marcel and Dekker (New York, NY), Parenteral Quality Control, Third Edition, describes validation and execution of testing schemes for parenteral quality control and emphasizes testing methodologies for the evaluation of package integrity, finished product contamination, and sterility. A more-general book, the 664-page Pharmaceutical Packaging Technology,