USP Draft Chapter <771> Ophthalmic Products – Quality Tests

 USP  Comments Off on USP Draft Chapter <771> Ophthalmic Products – Quality Tests
Sep 092016

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In the Pharmacopeial Forum 42(4) [Jun-Jul 2016] a revised draft of general chapter <771> Ophthalmic Products-Quality Tests has been published for comment. Read more about the draft USP chapter <771> describing quality tests for opthalmic dosage forms.–771–Ophthalmic-Products—Quality-Tests_15493,Z-PKM_n.html

In the Pharmacopeial Forum 42(4) [Jun-Jul 2016] a revised draft of general chapter <771> Ophthalmic Products-Quality Testshas been published for comment. The chapter has been previously published for comment in PF 41(5) [Sept.–Oct. 2015] and has become official on May 1, 2016 (USP 39). On the basis of comments received, the USP General Chapters—Dosage Forms Expert Committee is proposing to make the following changes to this chapter:

1. Universal Tests, Identification: If the identification test is nonspecific, at least two orthogonal nonspecific tests should be used.

2. Universal Tests, Sterility: The sentence reading, in part, “the immediate containers for ophthalmic products be sealed and tamper proof” is being replaced with a cross-reference to the subsection of the chapter <771> Universal Tests, Container–Closure Integrity.

3. Universal Tests, Leachables and Extractables: Information is being added when the evaluation of Leachables and Extractables is done: This assessment is done in a case-by-case approach during product development and re-evaluated when any changes are made to the product including, but not restricted to, changes in manufacturing process, formulation, and packaging material.

4. Specific Tests, Drop Size: Information is being added that the determination of drop size can be done by any appropriated validated procedure.

Additionally, minor editorial changes have been made to update the chapter to current USP style.

Comment deadline is September 30, 2016.

Following your free registration on the USP Pharmacopeial Forum website you can read the complete draft of general chapter <771>.

////////USP Draft Chapter,  <771>,  Ophthalmic Products, Quality Tests


Elaboration of New USP General Chapter <1220> – Analytical Procedure Lifecycle – announced

 regulatory, USP  Comments Off on Elaboration of New USP General Chapter <1220> – Analytical Procedure Lifecycle – announced
Jul 222016


On June 24, 2016, the USP announced the elaboration of a new general chapter <1220> regarding life cycle management of analytical methods. Read more about the new general chapter  <1220> “The Analytical Procedure Lifecycle“.


On June 24, 2016, the USP announced the elaboration of a new general chapter <1220> “The Analytical Procedure Lifecycle”. Input Deadline is July 29, 2016.

The suggested audience are drug product manufacturers, dietary supplement manufacturers, testing organizations, and drug product related regulatory agencies.

“An analytical procedure must be shown to be fit for its intended purpose. It is useful to consider the entire lifecycle of an analytical procedure when approaching development of the procedure, i.e. its design, development, qualification, and continued verification. The current concepts of validation, verification, and transfer of procedures address portions of the lifecycle but do not consider them holistically. This General Chapter intends to more fully address the entire procedure lifecycle and define concepts which may be useful.”

The approach is consistent with the concepts of Quality by Design (QbD) as described in ICH Guidelines Q8 (R2), 9, 10, and 11 and with the expected new ICH Guideline Q12 (Lifecycle Management).

Preliminary outline:

  • focal point: Analytical target profile (ATP), comparable to the Quality Target Product Profile (QTPP).


  • Procedure design and development,
  • Procedure understanding,
  • Preparing for qualification.



  • Routine monitoring,
  • Analytical control strategy,
  • Knowledge management,
  • Change control.

Anticipated proposed design phase activities:

Two Stimuli articles are scheduled for PF 42(5) [Sep.–Oct. 2016]:

  • Analytical Target Profile: Structure and Application throughout the Analytical Lifecycle,
  • Analytical Control Strategy.

Two stimuli articles have already been published:

  • Lifecycle Management of Analytical Procedures: Method Development, Procedure Performance Qualification, and Procedure Performance Verification. PF 39(5) [Sep.–Oct. 2013],
  • Fitness for Use: Decision Rules and Target Measurement Uncertainty. PF 42(2) [Mar.–Apr. 2016].

Additionally, the USP proposed a revision of general chapter <1225> “Validation of compendial procedures” in PF 42(2) [March-April 2016].
This chapter is being revised to incorporate a section on “Lifecycle Management of Analytical Procedures”. The revision is an attempt to better align the validation concept with the recently (July 2015) issued FDA guidance “Analytical Procedures and Methods Validation for Drugs and Biologics”, which also includes a section on “Life Cycle Management of Analytical Procedures”.

Estimated proposal for the new general chapter <1220> “The Analytical Procedure Lifecycle” is PF 43(1) [Jan.–Feb. 2017].

Furthermore, an USP and ECA Joint Conference and Workshop on Lifecycle Approach of Analytical Procedures will be held November 8-9, 2016 in Prague, Czech Republic.

For more information please visit the USP website – Notices- General Chapter Prospectus – The Analytical Procedure Lifecycle.



//////////The Analytical Procedure Lifecycle, USP, chapter <1220>


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