Retention Samples definition

Retention Samples. A fully packaged unit from a batch of finished Product stored for identification purposes. AMGEN Quality Specifications AMGEN approved set of analytical methods, requirements, and limits as used to judge the identity, purity and potency of all source materials, raw materials, and finished filled, labeled and packaged Product which comprises the Product. Stock Recovery The removal or correction of a non-marketed product used in a clinical trial for reasons related to product Safety, Quality, Identity, Potency, or Purity, that has not been marketed or that has not left the direct control of PARTNER.
Sample 1Sample 2
Retention Samples shall have the meaning set forth in Section 7.3.
Sample 1
Retention Samples. A Sample of a fully packaged unit from a lot of finished product which is stored for identification purposes, or in case additional QC testing is necessary.
Sample 1

Examples of Retention Samples in a sentence

  • VIFOR or its subcontractors shall properly store and retain (i) Reference Samples of Starting Materials released for and used to Manufacture Product (except water, compressed gases and highly volatile substances), (ii) Reference Samples of Bulk Product and (iii) Retention Samples of Product in conditions and quantity consistent with GMP.

  • Physical Properties of High Temperature Cure (60oC) Saltstone as Measured by MCT (90 day minimum curing period) from Moisture Retention Samples.

  • Sometimes also called Retention Samples as required by the FDA to be retained for the FDA in case the agency wants to analyse the sample.Collection of finished samplesReserve samples of drug product shall be collected for each batch, market order and each type of pack style control samples of drug product shall be collected in the same or simulated containers in which the drug has been actually marketed these shall be coded as Control sample.

  • Therefore, there is low risk of bias due to an unfavorable drill orientation.Sample securityThe Retention Samples were removed from the drill site and securely stored in a Mundubbera storage shed.

  • Retention Samples: Vet-Stem may also store a small sample of cells (retention sample) at no charge in order to provide cells for possible future expansion (culturing).

  • Women with other autoimmune diseases Outcome Measures Go to Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information Biospecimen Retention: Samples With DNA Blood samples will be collected and stored for future analysis.

  • These Reference and Retention Samples shall be kept for at least one (1) year after the expiry date of the products according to Good Manufacturing Practices.

  • Reference Document Important Terms, Conditions, and Limitations: Sample Retention: Samples analyzed by EMSL will be retained for 60 days after analysis date.

  • Biospecimen Retention: Samples With DNA Tumor tissue, bone marrow, blood, saliva, sputum, urine, feces, hair, surface skin Eligibility Criteria Go to Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.

  • All unused and used Study Drug tubes will be returned to the Sponsor or its designee for destruction at the end of the study except for the Retention Samples.

Related to Retention Samples

  • DNA sample means any material that has come from a human body and consists of or includes human cells;

  • cGMP means current Good Manufacturing Practice as set forth in the United States Federal Food, Drug, and Cosmetic Act, as amended, and includes all rules and regulations promulgated by the FDA thereunder.

  • API means American Petroleum Institute.

  • Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • Batch means a specific quantity of Product that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

  • SOPs has the meaning set forth in Section 3.7.

  • Manufacturing Process means any process for—

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • Drug sample means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.

  • Contaminated soil means soil that meets all of the following criteria:

  • Rubbing alcohol means any product containing isopropyl alcohol (also called isopropanol) or denatured ethanol and labeled for topical use, usually to decrease germs in minor cuts and scrapes, to relieve minor muscle aches, as a rubefacient, and for massage.

  • cGMPs means current good manufacturing practices as described in Parts 210 and 211 of Title 21 of the United States’ Code of Federal Regulations, together with the latest FDA guidance documents pertaining to manufacturing and quality control practice, all as updated, amended and revised from time to time;

  • Manufacturing Site means a location where a manufacturing

  • Supplier of water means any person who owns or operates a public water system.

  • Quality Agreement has the meaning set forth in Section 9.6.

  • Iatrogenic infertility means an impairment of fertility by surgery, radiation, chemotherapy, or other medical treatment affecting reproductive organs or processes.

  • Active Ingredient means any com- ponent that is intended to furnish pharmacological activity or other di- rect effect in the diagnosis, cure, miti- gation, treatment, or prevention of dis- ease, or to affect the structure or any function of the body of humans. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect.

  • Samples mean representative physical examples of materials, equipment or workmanship, used to confirm compliance with requirements and/or to establish standards for use in execution of the Work.

  • Disposable respirator means a respirator for which maintenance is not intended and that is designed to be discarded after excessive breathing resistance, sorbent exhaustion, physical damage, or end-of-service-life renders it unsuitable for use. Examples of this type of respirator are a disposable half-mask respirator or a disposable escape-only self-contained breathing apparatus (SCBA).

  • GTCs means these AVEVA General Terms and Conditions, which includes those terms and conditions set forth in the main body of the GTCs, and all of the various exhibits, addenda, and other documents incorporated into the GTCs.

  • Cultivation site means a location where cannabis is planted, grown, harvested, dried, cured, graded, or trimmed, or a location where any combination of those activities occurs.

  • Contractor Sensitive Information means any information provided by the Contractor to the Authority (disregarding any protective marking or assertion of confidentiality) which: is specified as Contractor Sensitive Information in Schedule 7 and has not lost its sensitivity according to the justifications and durations set out in that Schedule; and is exempt information pursuant to sections 33(1) or 36, 38 or 39 of FOISA (having regard for that purpose to the public interest there might be in disclosing such information as referred to in section 2(1)(b) of FOISA).

  • GMPs means all good manufacturing practices under Title 21 of the United States Code of Federal Regulations, as amended from time to time.

  • Grab sample means an individual sample collected in less than 15 minutes in conjunction with an instantaneous flow measurement.

  • COVID-19 symptoms means fever of 100.4 degrees Fahrenheit or higher, chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrhea, unless a licensed health care professional determines the person’s symptoms were caused by a known condition other than COVID-19.