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Online Audio Seminars come with 10+ Best Practice guides for easy implementation

 

Electronic Raw Data in Regulated Environments

Definition, generation and archiving for FDA Part 11, HIPAA and SOX compliance

Recorded

 

Implementing FDA's 21 CFR 111 for Dietary Supplements
Introduction, Strategies and Tool-kit for Implementation

Recorded

 

How much Validation is Enough?

Developing a Company Wide Strategy and Tools for Cost-effective Implementation

Recorded

 

GMP Compliance for Quality Control Laboratories: Step-by-Step

FDA Requirements and Tools for Implementation

Recorded

 

Recent Warning Letters and 483's Related to Computer Validation and Part 11

With Case Studies to Avoid and Respond to 483's and Warning Letters

Recorded

 

New  release on
August 25, 2009 

with 200 + eirs/483sb / warning letters

 

 

 

 

Labcompliance News, May 2010

FDA's Updates the Preapproval Inspections/Investigations Manual

FDA released a new version of the "Preapproval Inspection" Compliance Program Manual. The guide is targeted to inspectors but equally useful for inspected (Bio)Pharmaceutical industry. In addition to information on how inspections are prepared and conducted the guide also has lots of recommendations on what inspectors should specifically look at. Some of them are also applicable to routine cGMP inspections. Most interesting is the chapter on Raw Data Integrity with examples of data integrity problems that have been previously observed. They include: "Manipulation of a poorly defined analytical procedure and associated data analysis in order to obtain passing results",  "Exclusion of specific lots from the stability program to avoid submitting failed results", "Creating acceptable test results without performing the test" and "Using test results from previous batches to substitute testing for another batch". Inspectors are advised to "Audit the raw data, hardcopy or electronic, to authenticate the submitted data. In a new audio seminar attendees will learn how to define, manage and demonstrate integrity of electronic raw data.  The manual can be downloaded from the FDA website.

FDA-483 with 11 Observations Related to QC Laboratory Controls

The 483-Form has been handed over in the inspection close-out meeting to management of a pharmaceutical manufacturer. It is perfect case study to learn what can go wrong. Most observations are related mto inadequate supplier qualification, inadequate testing of raw material, inadequate SOP for OOS, lack of process validation, inadequate deviation from SOPs before authorization from management, lack of sampling plans, no justification for changing environmental conditions, test conditions not documented, no justification for only one cleaning validation run, test acceptance criteria not justified, no risk assessment performed to evaluate effect of deviations from SOPs, supplier's test results of components not validated. The FDA-483 can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-234.  Learn all about FDA GMP requirements related to quality control laboratories and how to avoid 483's in the Labcompliance audio seminar

PIC/S Publishes Example for Quality Risk Management Implementation

Since a couple of years Quality Risk Management (or QRM) has become a mandatory regulatory requirement towards healthcare organizations either they are active in the sectors of Medical Devices or in Pharmaceuticals. However, the practical methods for the implementation of these new requirements are still perceived as being singularly difficult to interpret and implement. Now an informal Working Group within PIC/S has developed an example of methodology for the implementation of Quality Risk Management (QRM) in industry. The example can be downloaded from the PIC/S website.

Labcompliance ISO 17025 Tutorial Updated

We have updated the popular tutorial for ISO 17025. Now it includes a management summary and a section with specific recommendation for implementation, for example, equipment verification, measurement traceability and measurement uncertainty. It also includes a step-by-step approach for getting accreditation and recommendations for internal and external audits. To access the free tutorial, click here.

3 Inspectional Observations Related to FDA's Dietary Supplement GMP's

FDA has started to enforce 21 CFR 111, FDA's GMP Regulation for 21 CFR 111. An example are three FDA-483 Inspectional Observations going to a manufacturer of dietary supplements. Deviations are related to Incomplete records of equipment cleaning and sanitation, raw material weight records incomplete, inadequate hygienic conditions. For example the observation state: "You did not make and keep documentation of the date of use, cleaning and sanitizing of the equipment used to prepare coating solutions for dietary supplement tablets", and "Your batch production records did not include the actual results obtained during a monitoring operation, Specifically, records for monitoring raw material in the weight room did not include each partial raw material weight and the identification of the equipment used", and "Your personnel did not use hygienic practices to the extent necessary to protect against contamination of dietary supplement ingredients. Specifically your personnel did not wear outer garments in a manner that protects against contamination of dietary supplement ingredients". The FDA-483 can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-233.  Learn all about 21 CFR Part 111 requirements and how to avoid 483's in the Labcompliance audio seminar

FDA Publishes  Guidance for Industry: ICH Q8, Q9, and Q10 - Questions and Answers

Since the Q8, Q9, and Q10 guidances were made final, experiences implementing the guidances in the ICH regions have given rise to requests for clarification. This new FDA question and answer (Q&A) document is intended to clarify key issues. The guidance reflects the current working procedure of the ICH Quality Implementation Working Group (Q-IWG) for implementing the Q8, Q9, and Q10 guidances. Discussions are related to process validation, quality by design, design space, real time release testing vs. product end-testing, benefits of pharmaceutical quality system, adjusting of process parameters throughout the product life-cycle, and others. The guide can be downloaded from the FDA website.

FDA Inspection Reports - Ideal  Case Studies for Dietary Supplement GMPs

FDA Establishment Inspection Reports (EIR) are quite useful to learn about the complete inspection process, e.g., who is interviewed, where the inspection focus is, what documents are reviewed, what questions are asked and if the answers are satisfactory. This is especially important for new regulations with little information on what FDA's interpretation. A good example is an EIR related to the new FDA's new GMP regulation for Dietary Supplements.
The EIR includes all aspects of the regulations. Specific sections are:
Persons interviewed (by function), personnel, training, physical plant and grounds, cleaning and pest control, equipment calibration and sanitation, production and process control, examination of incoming material, quality control, qualification of suppliers, COA, handling returned dietary supplements and customer complaints, review of batch records by QA, laboratory testing, packaging and labeling operation, avoiding product contamination during holding and distribution, closing discussion with QA manager, The company passed the inspection without any inspectional observations. The EIR can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-235.  Learn all about 21 CFR Part 111 requirements and how to avoid 483's in the Labcompliance audio seminar

Free Document of the Month

As a 'Thank You' for our visitors Labcompliance offers every month one document for free. This month's document is the SOP: Validation of Spreadsheet Applications. To download your free copy, go to the Spreadsheet Compliance website.  Scroll down and click on the corresponding ICON on the left (offer expires on May 10, 2010). Labcompliance offers more than 120 SOPs that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here.


Audio Seminar Schedule

 

  1. Implementing FDA's 21 CFR 111 for Dietary Supplements
    Introduction, Strategies and Tool-kit for Implementation
    May 27, 2010
  2. Electronic Raw Data in Regulated Environments
    Definition, generation and archiving for FDA Part 11, HIPAA and SOX compliance
    June 10, 2010
  3. GMP Compliance for Quality Control Laboratories: Step-by-Step
    FDA Requirements and Tools for Implementation
    June 24, 2010
  4. Analytical Instrument Qualification According to USP <1058>
    With SOPs, Templates and Examples for Easy Implementation
    July 8, 2010
  5. Recent Warning Letters and 483's Related to Computer Validation and Part 11
    With Case Studies to Avoid and Respond to 483's and Warning Letters
    July 22, 2010

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