WIXLIB

Quality & RegulatoryZero-Particulates Goal Promotes Continuous Improvement continued from page 1A thorough understanding of the failuremode that results in particle generationand contamination in injectable productsis like winning the half-battle towardthe zero-particulate goal. Setting up acontinuous improvement program andcontrolling variability by the qualificationand standardization of all materials, components and equipment parts can help getone step closer to this challenging goal.Constant collaboration and open communication among sterile-product manufacturers, suppliers, and regulatory agencies isan essential element in this endeavor.It is not a question of whether Zero Particles is a realistic goal, but it is desirablefor patient safety and drives continuousprocess improvement!Figure 1 Continuous Improvement Cycle for Visible Particulate-Free Injectable ProductsNext, further in-depth analysis of theserepresentative particle samples can beconducted using spectroscopic or otherfingerprinting techniques using such technologies as FTIR, Raman or SEM/EDS.This ultimate level of identification provides meaningful information about thenature of the particles. The findings fromthis level of identification are helpful forscouting the source of the particles in theproduction area and incoming materials.Having identified the nature of the particles, the next step is to identify the source.This requires scanning through everythingthat comes into the vicinity of the asepticprocessing area, adeptly collecting particlesamples and running a similar characterization test.The entire program can best be managedby a shop-floor cross-functional teamusing a predefined protocol that governsthe complete process of sampling, testing,investigation, corrective and preventativeactions and follow-up. A well-defined frequency of conducting such an exercise helpsmaintain continued control over potentialparticulate sources and improves on theprocess. Special attention should be paid ifany atypical particles or unusual rejectiontrends are observed during inspection or thesubsequent identification process.Implementing Qualification CriteriaImplementing good testing and qualification criteria, with respect to the particleshredding characteristic of each material,component and equipment part enteringinto the aseptic processing area, is thekey to good particulate control in theproducts. This entails constant collaboration and benchmarking with the suppliers to build and maintain the quality ofall input materials by setting mutuallyagreeable specifications. Choosing theright fit-for-purpose materials or components and assigning a usage life to each ofthem is an important part of this controlstrategy. A change in any of the materials,components, equipment or parts—however trivial it might look—must meetthose qualification criteria to avoid laterconsequences.References1. U.S. Pharmacopeial Convention. USP 1790 Visual Inspection of Injections. In USP43–NF38, p. 8587.2. Shabushnig, J G. The Changing VisualInspection Regulatory Environment.Presented at 2021 PDA Visual Inspection Forum, 14-15 April, 2021.Other ReadingLangille, S E. Visible Particulate Contamination Control for Injectable Products: ALife-Cycle Approach. PDA J Pharma SciTech May 2020, 74(3), 359-366.Johns, J., et al. Achieving Zero Defectsfor Visible Particles in Injectables. PDA JPharma Sci Tech November 2018, 72(6),640-650.About the AuthorSubrata Chakraborty leadsthe GxPFONT ConsultingGroup as PrincipalAdvisor and has over 24years of experience inhandling pharmaceuticalmanufacturing and qualityoperations in various capacities withexpertise in aseptic technology. He alsovolunteers for the PDA Letter EditorialCommittee for the Asia-Pacific region.Letter July 20217

pda.org/2021remoteaudits2021 PDARemote Auditsand InspectionsWorkshopREGISTER BY31 AUGUSTTO SAVE!Is Your Company Ready for a RemoteAudit or Inspection?Join PDA on 8-9 September for a two-day interactive Workshop to gain the tools and practical solutions youneed to successfully overcome challenges in preparing for and hosting remote audits and inspections.Through presentations, case studies, and video role play drawing on industry experiences, this Workshop willexplore important topics, including: The benefits and challenges of hosting and conducting remote audits and inspectionsApplying a risk-assessment approach during audits and inspectionsAnticipating perils and pitfalls: The impact of culture on communication during remote auditsFirst-hand experiences of auditors and regulators in conducting virtual audits of remote internaloperations and suppliersFind out what your company needs to do before and during your remote audit or inspection to ensure success!For more information and to register, visit pda.org/2021remoteaudits13-14 SEPTEMBER 2021LIVE. INTERACTIVE. ONLINE#2021remoteaudits

Quality & RegulatoryMy Journey to Japan — Sort OfMarilyn L. Foster, PDAAlmost four years in the making, thefinal guidance document from the PDAJapan Chapter is well worth the wait.Environmental Control and Maintenancein the Manufacturing of Non-Sterile DrugProducts: Kansai Study Group (KSG) ofthe PDA Japan Chapter was added to thePDA Bookstore on 24 June, the culmination of a journey that began in July 2017.My first introduction to the topic camefrom former PDA VP for Scientific andRegulatory Affairs and current PDA JPSTEditor Richard Levy, PhD, when heasked me to work with Keisuke Inoue,Takeda, and Osamu Shirokizawa, Lifescientia, to prepare an article for the Journalreviewing the 90-page document and itsbackground. A series of back-and-forthemails ensued, as I stumbled through thelinguistics involved in understanding thedifferent meanings of technical terms andconcepts in the Japanese English versionof the article. One instance really caughtme up short when I saw the diagram forthe entrance and exit paths of the dressingand undressing rooms.In the process, I learned that in many Japanese pharma manufacturing facilities, thetechnicians are provided with uniformsto wear, rather than coverings over theirstreet clothes; hence, the separate dressing/undressing rooms for men and women. Idiscovered more about the developmentof the guidance document that formedthe basis for the Journal article when Iviewed the poster Inoue and Shirokizawapresented at the “12th Annual PDA GlobalConference on Pharmaceutical Microbiology” in October 2017. Their exhibitionwas very enlightening and meeting thegentlemen from Japan in person was a realtreat. Finally, the faces behind the emails!The opportunity proved valuable to Inoueand Shirokizawa as well; in addition toattending the conference, they toured thethen-new TRI training center. Shirokizawa wrote: “We received a lot of visitors toour poster throughout the sessions. Wehad insightful discussion with them.***[AtTRI] We saw PDA has been providing avariety of training to learn about manykey features of aseptic processing. Weknow how effective and important handson training is to any trainee.”The sojourn through the manuscriptsubmission process, needless to say, wasa lengthy one. We tapped into the PDAmembership to find reviewers knowledgeable about the subject. The first round ofreviewers commented that it was difficultto make a decision about a paper based ona document they couldn’t see. While thefull guidance document had been translated to English, the initial version neededadditional editing to convert some of theterms to their American English equivalents. And I became a translator.Over the years of sending sections ofmy “translations” for the JPDA teamto accept, reject or amend, we began arespectful business friendship: Shirokizawaand Inoue became the more informalOsamu-san and Keisuke-san. We learneda little about one another’s lives, culturesand perspectives. Osamu volunteered towork on the TR 29 revision team and experienced the global collaborative effort ofdeveloping technical reports. He was latervoted to join the PDA Board of Directors.Osamu served as the primary contactbetween the PDA Publishing Group andthe KSG, who provided feedback on allof the translated sections. I was humbledby the experience of knowing so manytop business leaders took the time to readmy many, sometimes minute, commentsand changes in their valuable document.They truly valued the opportunity to shareall they had learned through the originalsurvey they conducted of pharmaceuticalmanufacturers in Japan and the best practices they had developed as a result.In October 2019, Osamu stopped over ona business trip to meet again with WalterMorris, PDA Sr. Director, Publishing &Press Relations, and me at PDA’s Bethesdaoffice. We spent some time going overthe plans and timelines for converting thechapters of the guidance document andchecking on the progress of the Journalarticle. It was a great opportunity to jugglewhat we said and how they understood itand vice versa. (This was when I learnedabout the dressing rooms.)The time between now and then comprised numerous rounds of editing, commenting, revising, proofreading, and correcting on both sides of the world and thestrings of emails that bridged the globe. Aglobal pandemic interrupted the processand slowed down everything it didn’t stopimmediately. And, at last, this productionled to the final typesetting and publishingof, in my humble and completely unbiased opinion, both masterpieces.To make a long story short, the final JPDAarticle, “Overview of ‘The Study in Riskbased Manufacturing EnvironmentalControl for Non-sterile Drug Products’ byOsamu Shirokizawa, Keisuke Inoue andTsutomu Kamikukita, was published as anAccepted Article on the PDA JPST websiteon 14 May 2021. And the English translation of the Environmental Control and Maintenance in the Manufacturing of Non-SterileDrug Products: Kansai Study Group (KSG) ofthe PDA Japan Chapter was made available inthe PDA Bookstore on 24 Jun 2021.I hope sometime to visit our associates inJapan to see what else I can learn of theirculture. In the meantime, pick up a copyof their guidance for yourself or yourcompany. I am sure you will find somevaluable and practical advice!Letter July 20219

President’s MessagePDA Mid-Year UpdateRichard Johnson, PDASince early 2020, the entire world has been in the grips of a global pandemic. As of 4June 2021, over 170 million cases of COVID-19 have been reported, with more than 3.7million deaths. Each of us, directly or indirectly, has been impacted by this pandemic orits effects.On a positive note, more than two billion doses of vaccine have been administered worldwide, largely through the efforts of our community, which has developed, manufacturedand distributed vaccines with unprecedented speed. In some parts of the world, we areseeing a gradual return to “normalcy,” but unfortunately, in other parts of the world, thepandemic is still raging, and vaccine administration has not yet reached desirable levels.We understand some volunteers may be concerned how PDA is weathering the pandemic.Richard Johnson, PDA PresidentSince March of last year, our staff has been working mostly from home. We have had toshift many of our activities from in-person to virtual formats. This has been challengingand has affected our finances.PDA is financially very sound, and through diligent management, PDA still has morethan 12 months of reserves, despite the decrease in revenue through 2021.We have had to react to the changing situations and, although we had hoped to beginface-to-face meetings in Q-2/3, for most of 2021, our conferences will be virtual.Training, Membership and Publications revenue is starting to recover.We have not laid off any employees due to the pandemic, but we have not filled somevacancies. We are gradually starting to fill some of these positions.Our Board of Directors, Advisory Boards, Committees and Task Forces are all meetingvirtually. Thank you to all the volunteers who continue to contribute!These are challenging times for the whole world, including PDA. This year, PDA iscelebrating its 75th anniversary. With your continued support and participation, PDA willcontinue to Connect People, Science and Regulation for many years to come.10Letter July 2021

Ivy Louis . aining r T. Subrata Chakraborty. Cipa. Andiyanto Sutandar. P sia ADVERTISING SALES Vice President, Sales. David Hall 1 - ext. 1 hallpda.org. The P etter is puished times per ear in print eusive or P memers. Arties puished in the P etter do not represent the oia positions o P n ut are the opinions o the authors sumitting the arties