Description
This guidance is intended to aid drug manufacturers (including ancillary testing laboratories) in calibrating U. S. Pharmacopeia (USP) Dissolution Apparatus 1 and 2 to help assure that critical parameters associated with the dissolution apparatus meet certain mechanical calibration (MC) tolerances. This guidance recommends that an enhanced MC procedure (such as the one recommended in this guidance) can be used as an alternative to the current Apparatus Suitability procedure for Dissolution Apparatus 1 and 2 described in USP General Chapter Dissolution. Regardless of whether the enhanced MC procedure or Apparatus Suitability procedure is used, the guidance also recommends that appropriate measures be taken to control the following sources of significant variability in dissolution testing: dissolved gases, vibration, and vessel dimensions.
Scope & Applicability
Stakeholders
4Entity responsible for submitting NDINs
Endorsed the use of enhanced mechanical calibration
Includes laboratories involved in drug testing and calibration
Entities that may collect patient experience data
Regulatory Context
Attributes
1Source of significant variability in dissolution testing; Symmetry and dimensional attributes affecting dissolution performance
Identified Hazards
Hazards
2Source of significant variability in dissolution testing; Can cause bubbles to form around dosage forms affecting results
Source of significant variability in dissolution testing; Source of significant variability in dissolution testing results
Related CFR Sections (3)
- 21CFR314.70§ 314.70 Supplements and other changes to an approved NDA.
(a) Changes to an approved NDA.Read full regulation →
- 21CFR211.68§ 211.68 Automatic, mechanical, and electronic equipment.
(a) Automatic, mechanical, or electronic equipment or other types of equipment, including computers, or related systems that will perform a function satisfactorily, may be used in the manufacture, processing, packing, and holding of a drug product. If such equipment is so used, it shall be routinelyRead full regulation →
- 21CFR211.160§ 211.160 General requirements.
(a) The establishment of any specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms required by this subpart, including any change in such specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms, shall be drafted Read full regulation →
Related Warning Letters (2)
- 2025-05-20
CGMP/Finished Pharmaceuticals/Adulterated
NWL Netherlands Services B.V.
- 2023-09-05
CGMP/Finished Pharmaceuticals/Adulterated
Lex Inc.
See Also (8)
- CPG Sec. 425.400 Computerized Drug Processing; Input/Output Checking (Status: Final)
- Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (Status: Final)
- Process Validation: General Principles and Practices: Guidance for Industry (Status: Final)
- Blood Establishment Computer System Validation in the User's Facility: Guidance for Industry (Status: Final)
- BLA for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System: Guidance for Industry (Status: Final)
- Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry: Guidance for Industry (Status: Final)
- Data Integrity and Compliance With Drug CGMP: Questions and Answers: Guidance for Industry (Status: Final)
- Development and Submission of Near Infrared Analytical Procedures (Status: Final)