Prepare and manage required SOPs for cGMPcomplianceTrain staff in cGMP policies and compliancePrepare and execute Quality Agreements with contractmanufacturers (CMOs/CDMOs)Serve as the Release Authority on behalf of the client

Assess and consult on the level of compliance ofmanufacturersProvide written gap analysisPropose compliance improvement opportunities

Define required CAPAEstablish missing or incomplete quality systemsPrepare needed SOPsTrain both manufacturing and quality unit staff

DSI has managed operational Quality Assurance functionsfor biopharmaceutical companies in all stages ofdevelopment, as well as commercial operations. We haveprovided management of quality investigations, deviations,out-of-specification testing, change control, commercialcomplaints, and batch record review and release. Inaddition, we have facilitated QA review of CMCdocumentation including manufacturing processdevelopment protocols and validation reports, productspecifications, manufacturing master records, and testmethods.

The DSI Quality Team is focused on providing the highestlevel of cGMP Quality Assurance for all stages ofdevelopment and manufacturing. Our quality team is madeof pharmaceutical industry professionals with years ofindustry experience. Our team is experienced in API andDrug Product cGMP compliance for both small and largemolecules, and also medical device cGMP. We have strongtechnical skills in aseptic processing and sterile productsmanufacturing, and we bring you extensive experience inanalytical chemistry and microbiology laboratory operations.

QA Services

cGMP Auditing

cGMP Remediation & Compliance ImprovementDSI works directly with the manufacturer’squality unit to implement improvementprograms:

Review and recommend opportunities for improvementof batch records and other operations documentation toimprove shop floor and QA release efficiencyAdvice on the suitability of facilities for API, largemolecule, and sterile product manufacturing to ensureGMP complianceAdvice on design and operation of environmentalmonitoring systems for “clean rooms” and othercontrolled manufacturing facilitiesProvide an organizational strategy for conducting andreporting sterility failure investigations to assess rootcause and define corrective action and preventativeactions

Help create the critical process parameter analysisexperimental plan to be consistent with Quality Design(QbD) conceptsDraft the process validation protocol to be consistentwith QbD conceptsHelp organize the process validation plan or validationdata

Assist in the selection of subject matter experts (SME)Train SMEs on proper procedures for responding toinvestigator questionsSet up documentation “war room”Ensure all previously identified CAPA are completePerform final housekeeping inspection to ensure afacility is fully preparedOrganize daily de-briefing and assignment of follow-updutiesAdvice on response to all inspection observations

Prevention of Compliance issuesMaintain GMP ComplianceCost-EffectivenessEfficient preparation for regulatory agency inspectionPost-inspection Rapid Response and Remediation

Manufacturing Operations

Validation

Preparation for Agency Inspection (FDA PAI)Train Quality staff to manage a regulatoryauthority inspection, including:

Benefits

Knowledge: We know what is important to FDA.Experience: Seasoned GMP consultants, each with atleast ten years in GMP.Holistic Approach: In addition to process andprocedures, we review the organization, employeeengagement, systems, training, etc.Root Cause Analysis: We focus our resources ondetermining and rectifying the root cause.Strong Project Management: Regardless of project size,each engagement is assigned a project manager withresponsibility for project success, acting as a single pointof contact for you and your team.Value: Our consultants are competent and efficient,producing results as quickly as possible. We do notbelieve, as some of our competitors do, that the bestresults are obtained by engaging legions of consultantsto rewrite SOPs.Speed: Time is critical when manufacturing issues arise.We mobilize quickly to assist our GMP clients worldwide.

Good Manufacturing Practices (GMP) ServicesDSI provides comprehensive, hands-on GMP QualityCompliance services to the pharmaceutical, medical device,and biotechnology industries. We have been providing GMPconsulting services to clients worldwide for the past 15years.

Our GMP consulting services are characterized by:

Benefits of Having a GMP ConsultantGMP Consultants can bring expertise and experience thatyour business does not have. They can help manage andcomplete a compliance project that requires specializedskills or help get work done efficiently.

DSI: GMP Compliance ExpertsAs our client, you can expect a partner that will not only behands-on but will also work alongside you to provide qualitycompliance services as well as the strategy and training tohelp you improve your quality systems, thus mitigatingfuture risk.

We will work with you to identify the appropriate GMPConsultant based on your organizational requirements andneeds. We will then work with you to define, draft, andexecute a plan to optimize your GMP quality andcompliance programs.

ProductionFacilities and EquipmentLaboratory controlsMaterialsPackaging

Policies, Standards, SOP Preparation, and/orOptimizationBatch Record ReviewRemediation Project ManagementQuality Systems Development, Assessment, RemediationRoot Cause Investigations and CorrectiveAction/Preventive Action (CAPA) RemediationThird-party GMP and GLP Compliance AuditingMock FDA/International Regulatory Agency Inspections &PAI ReadinessDue Diligence Compliance Inspections, Audits, andAssistanceFDA Actions (483 Observations, Warning Letters,Consent Decrees) RemediationData Integrity ComplianceMergers & Acquisitions (M&A) regulatory integration

DSI has provided biotech, and pharmaceutical consultingservices to companies worldwide. We have consulted withcompanies of every size on every continent supplying themwith viable and efficient GMP Compliance solutions. DSItakes a proven, active approach to listening and addressingour clients’ specific needs to ensure their quality andregulatory operations are in compliance with currentindustry standards, as well as FDA and internationalregulations. DSI is the GMP Services company of choice forthe pharmaceutical, medical device, and biotechnologyindustries.

GMP Service OfferingsBy utilizing our consulting services, you can address thefollowing:Design of Quality Systems for:

Within the Quality System, we can provide thefollowing services:

WWW.DSINPHARMATICS.COM

DSI Solutions

D S I , a P L G C o m p a n yP . O . B o x 5 3 2 , H a r l e y s v i l l e ,P e n n s y l v a n i a , 1 9 4 3 8 P : 8 5 5 - 8 0 5 - 8 4 0 2 s o l u t i o n s @ d s i n p h a r m a t i c s . c o m

C o n t a c t U s