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.
Retention Samples shall have the meaning set forth in Section 6.3.
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.

Examples of Retention Samples in a sentence

  • Retention Samples A fully packaged unit from a batch of finished Product stored for identification purposes.

  • Retention Samples A fully packaged unit from a batch of Drug Product.

  • Sellers also agree that Buyers shall have reasonable access to all Retention Samples and Batch Records retained by Sellers for a period of one (1) year beyond any expiration date pertaining to any applicable Products, but only to the extent not needed by Sellers.

  • Supplier shall provide Adolor with reasonable access to and portions of the File Retention Samples for testing and other purposes upon Adolor’s request.

  • 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.

  • 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.

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

  • Amphastar shall provide Eton with access to and portions of the Retention Samples for testing and other purposes upon request.

  • In the event of any dispute as to whether the Product may be rightfully rejected by Forest, such Product shall be tested, using the Product from the shipment or shipments in question, for conformance with the Retention Samples and Specifications and acceptance criteria by an independent GLP/cGMP certified laboratory of recognized repute, acceptable to both Parties who shall analyze the Product using such procedures and tests as the laboratory may consider necessary or appropriate to reach conclusion.

  • Upon CUSTOMER’s request, AVECIA will provide CUSTOMER reasonable access to such Retention Samples without additional charge.

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 Practices as specified in the United States Code of Federal Regulations, ICH Guideline Q7A, or equivalent laws, rules, or regulations of an applicable Regulatory Authority at the time of manufacture.

  • 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 means standard operating procedures.

  • 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, as applicable, current good manufacturing practices as described in:

  • Manufacturing Site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • 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 the clinically active material(s) that provide pharmacological activity in a pharmaceutical product (excluding formulation components such as coatings, stabilizers, excipients or solvents, adjuvants or controlled release technologies).

  • Samples means physical examples which illustrate materials, equipment or workmanship and establish standards by which the Work will be judged.

  • 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.

  • 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.

  • Contractor Software means software which is proprietary to the Contractor, including software which is or will be used by the Contractor for the purposes of providing the Services.