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| Other Laboratory Operations Food and Drug Administration |
| DOCUMENT NO.: III-05 | VERSION NO.:1.2 | Section 5 - Analysts on Inspection | EFFECTIVE DATE: 10/01/2003 | REVISED: 06/06/2008 |
5.2 Analysts on Inspection
During the course of an analyst's career with FDA, they will often be
expected to participate in the inspection of FDA regulated firms. Analysts
bring scientific expertise, knowledge, and other skills to an inspection team.
Participation may include making and recording observations to evaluate manufacturing
processes, practices and conditions; reviewing the firm's records; asking
questions of the firm's management or employees; collection of samples;
and participation in the discussion of the close out meeting or exit interview
with the firm's management. Often the analyst will assist in the
preparation of sample collection reports, observations, and establishment inspection
reports.
5.2.1 Preparing for an Inspection
An analyst on a team inspection lends scientific support and technical expertise
to the inspection team. The type of team inspection that an analyst will participate
in depends upon their area of expertise and the type or complexity of inspection
being performed. Chemists, microbiologists, biologists, entomologists, sanitarians,
biochemists, organoleptic specialists, and engineers all play an important role
in a team inspection.
Prior to beginning a team inspection, preparation for the upcoming inspection
is the key. Review the district files of the firm to be inspected and acquaint
oneself with the firm's inspectional history, testing practices, and products.
Review the previous Establishment Inspection Reports (EIRs) and FDA 483 items.
Review the inspectional assignment in FACTS and note what Program Assignment
Code (PAC) is listed in the assignment (this will enable the analyst to locate
the corresponding Compliance Program). Meet with the Consumer Safety Officer
(CSO) and other team members before beginning the inspection. Also review
any applicable Laws, Regulations, Compliance Programs, Compliance Policy Guides,
and Inspectional Guidance documents relating to the type of team inspection being
performed. Do not forget to read the Investigators Operational Manual (IOM).
The IOM is the primary source of guidance regarding Agency policy and procedures
for establishment inspections and sampling by field investigators and analysts. Knowing
what the analyst role is, and what will be expected of each team member is crucial.
In order to prepare for an inspection, an analyst will need to:
- Read the hard copy or FACTS inspectional assignment to determine
what is to be covered.
- Review the File Jacket for the previous inspection(s); note previous
deficiencies and if there were corrective actions.
- Review previous EIRs and 483s.
- Review the assigned Compliance Program.
- Review the related sections of the CFR.
- Review associated Guidance Documents.
Depending on the type of team inspection, general responsibilities may include
reviewing analytical data from production, manufacturing or testing facilities;
reviewing and evaluating test methods; and observing actual analytical testing
or manufacturing being performed at the facility to assure that good manufacturing
practices and good laboratory practices are being used. An analyst may
need to evaluate whether laboratory equipment is properly calibrated or qualified.
Also, an analyst may need to evaluate sanitation practices and environmental
conditions that might affect safe product packaging and production.
During the inspection, an analyst may be asked to collect samples. Sampling
operations are carried out using techniques to ensure that the sample is representative
of the lot; that the sample of the product is in the same condition as it was
before sampling, and that the collection technique does not compromise the compliance
status of the lot. The type of samples that may be collected include in-line
samples, environmental samples, sanitation samples, water samples, finished product
food and drug samples, as well as the various controls associated with these
samples. Make sure that the sampling supplies are present and in good condition
prior to collection of samples. Read the corresponding Compliance Program and
the IOM if samples are to be collected. For microbiological inspections, sampling
products using aseptic techniques is critical. Aseptic sampling techniques are
used to assure that the microbial load of a product is not increased or introduced
by a poor sampling procedure. The use of sterile sampling implements and
containers, as well as a prescribed sampling method, defines aseptic sampling.
Do remember that during the inspection, safety is paramount. When conducting
an inspection or collecting a sample at a firm, make sure that the proper protective
clothing and safety equipment are used. The analyst may need to wear
a jumpsuit, lab coat, safety glasses, safety shoes, hard hat, hearing protection
or respiratory protection. In a sterile drug facility, there may be precise
gowning procedures. Guidance should be provided by the firm's management. The
analyst can also contact the Regional Industrial Hygienist or ORA Safety and
Occupational Health management and discuss any concerns either prior to or
during the inspection. The analyst will also need to discuss with the
inspectional team and the firm's management any food or drug allergies which
may preclude participation in certain aspects of the inspection.
5.2.2 Starting an Inspection
A FDA-482 Notice of Inspection is presented to the most responsible person
upon entering a firm. Credentials are also displayed at this time. The
analyst will be expected to display their FDA credentials. Securing official
credentials through a supervisor may take 1-2 weeks and is done prior to going
on inspection. In the case of an international inspection, only credentials
are displayed since the Notice is not issued. Analysts must secure an official
passport prior to overseas travel. Depending on the country, an official visa
may also be needed for entry into the country. These requests may take 2-5
months to process through the Division of Field Investigations. The investigator
will usually give a brief synopsis of why the inspection is occurring. In
the case of a directed or for-cause inspection, the investigator may be vague. Do
NOT add to the investigator's comments unless discussed
previously.
5.2.3 Regulatory Notes and
Exhibits
During the inspection, notes are expected to be recorded. These regulatory
notes are recorded in a bound notebook. Note-taking is described in Subchapter
190 Regulatory Notes of the IOM. This subchapter identifies what should
be included and what should not be included in inspectional notes or diary notebook. Keep
in mind these notes are considered part of the inspection and are subject to
the Freedom of Information Action (FOIA). A return address should also
be located on the notebook in case it is lost.
An analyst is to document what was reviewed and observed during the inspection
in the notebook. The inspectional notebook is factual. The analyst may want
to document product names, batch numbers reviewed, names and titles of people
spoken to during the inspection and who provided information, SOP numbers of
the methods reviewed, raw material, in-process or finished product testing
reviewed (e.g., purity assays, dissolution results, objectionable microorganism
plate counts) or, the systems reviewed (e.g., sampling, water system testing,
or environmental monitoring).
Exhibits are any documents collected during an inspection which are included
in the EIR as evidence of observations. Exhibits should contribute to the objective
of the assignment and the clarity of the report. In some cases exhibits
may be physical materials that constitute evidence for establishing violative
conditions. These types of exhibits are prepared and submitted under an
INV sample number. In-plant photographs are exhibits as well; however they
are submitted under seal in a FDA-525 envelope as an exhibit to the EIR or with
a documentary sample.
During the inspection, it is best to collect photocopies of methods, results,
standard operating procedures, schedules, etc. that may be used to assist in
the description of a process or an objectionable condition. Documents not included
in the report should be properly destroyed or shredded. Relate this practice
to the firm at the time of collection. In the case of CD-ROMs, the district
office may have a policy addressing their disposal or the firm may request the
return of the CD-ROM. Either way, state in the report how the CD-ROM was
treated.
The "Exhibits" section of the EIR contains a list of all exhibits
cited in the EIR. Each exhibit is labeled with the:
- Reference number,
- Name of the firm,
- Dates of the inspection,
- Initials of the team members performing the inspection, and
- Number of pages in the exhibit.
In the EIR, they are listed with their reference number and a title or description. The
analyst and investigator decide how exhibits will be numbered (i.e., whether
the analyst's exhibits will be included with those of the investigator and
numbered sequentially or included in a separate appended report and numbered
separately).
5.2.4 Inspections and Travel
Travel is outlined in the IOM under Subchapter
110 Travel of CHAPTER
1 - ADMINISTRATION .
There are many instances when an analyst will be requested to travel outside
of the local travel area or to another District. In these instances,
the analyst needs to follow the District and Regional policies. If planning
to stay overnight, the analyst will need to prepare a Travel Authorization
and have it approved PRIOR to the start of the travel.
For on the road inspections, a lap top computer can be a very helpful tool
to have at the inspectional location. With a lap top computer, reports can
be worked on in the evenings and will allow the analyst to contact various
resources for assistance after-hours. Finding resources during the day
while at a firm can be quite challenging.
5.2.5 Sample Collection
Sampling is outlined in the IOM in SAMPLING. This chapter explains the step
by step process for collecting samples. Refer to Subchapter 400 - General prior
to the collection. It also describes the types of samples typically collected
during an inspection: Official and Documentary. An Official sample is
defined in Section 405.1 and Documentary in 405.2. A receipt for sample is
issued when collecting physical samples. This receipt is issued after
the completion of the inspection but prior to leaving the premises. This
process is clearly explained in sections 401.3 Receipt for Sample, 412 Receipt
for Samples, 412.5 Prescription Drugs (Non-Controlled), 412.6 Preparation of
FDA 484, and 412.7 Routing of FDA 484. Documentary samples usually need the
issuance of an affidavit. Affidavits are explained in section 433 AFFIDAVITS. The
form typically used is the FDA 463a. Affidavits are crucial since these
documents are used to tie all the records collected to the objectionable conditions
and show interstate transportation. If an analyst writes an affidavit,
be sure to consult the local Investigations or Compliance Branch for the proper
style as well as review this section in the IOM.
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