Subpart H - Acceptance Activities (§§ 820.80 - 820.86) Subpart I - Nonconforming Product (§ 820.90) Subpart J - Corrective and Preventive Action (§ 820.100) Subpart K - Labeling and Packaging Control (§§ 820.120 - 820.130) Subpart L - Handling, Storage, Distribution, and Installation (§§ 820.140 - 820.170). Table 1—Comparison of 21 CFR Part 820 to ISO 21 CFR Part 820 Quality System Regulation sections (“the Regulation”) ISO clause(s) (“the Standard”) Similarities, significant differences, and key requirements N/A 0.1 Introduction, general 0.2 Clarification of concepts 0.3 Process approach 0.4 Relationship with ISO 9001.
The terms listed in this section have the following meanings for purposes of this subpart:
Biological product has the meaning set forth in § 3.2(d) of this chapter. A biological product also meets the definitions of either a drug or device as these terms are defined under this section.
Code of Federal Regulations Title 21, Volume 8 Revised as of April 1, 2014 CITE: 21CFR820 TITLE 21-FOOD AND DRUGS CHAPTER I-FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H-MEDICAL DEVICES PART 820 QUALITY SYSTEM REGULATION Subpart A-General Provisions Sec.
Combination product has the meaning set forth in § 3.2(e) of this chapter.
Constituent part is a drug, device, or biological product that is part of a combination product.
Co-packaged combination product has the meaning set forth in § 3.2(e)(2) of this chapter.
Current good manufacturing practice operating system means the operating system within an establishment that is designed and implemented to address and meet the current good manufacturing practice requirements for a combination product.
Current good manufacturing practice requirements means the requirements set forth under § 4.3(a) through (d).
Device has the meaning set forth in § 3.2(f) of this chapter. A device that is a constituent part of a combination product is considered a finished device within the meaning of the QS regulation.
Drug has the meaning set forth in § 3.2(g) of this chapter. A drug that is a constituent part of a combination product is considered a drug product within the meaning of the drug CGMPs.
Drug CGMPs refers to the current good manufacturing practice regulations set forth in parts 210 and 211 of this chapter.
HCT/Ps refers to human cell, tissue, and cellular and tissue-based products, as defined in § 1271.3(d) of this chapter. An HCT/P that is not solely regulated under section 361 of the Public Health Service Act may be a constituent part of a combination product. Such an HCT/P is subject to part 1271 of this chapter and is also regulated as a drug, device, and/or biological product.
Manufacture Black gaming keyboard and mouse. includes, but is not limited to, designing, fabricating, assembling, filling, processing, testing, labeling, packaging, repackaging, holding, and storage.
Title 21 Cfr Part 820 Pdf
QS regulation refers to the quality system regulation in part 820 of this chapter.
Single-entity combination product has the meaning set forth in § 3.2(e)(1) of this chapter.
21 Cfr 820 Part 11 Pdf
Type of constituent part refers to the category of the constituent part, which can be either a biological product, a device, or a drug, as these terms are defined under this section.