Are YOU presently concerned or
involved in any of the following?
.It is important that you prepare and respond to each of these
situations carefully and thoughtfully. Failure to properly act
in these situations could possibly result in your business being
shut down, criminal/civil actions being filed, and/or huge financial
losses. We have seen many companies proceed without guidance
and have ended up wasting a lot of time and money by not involving
expert assistance during these critical situations.
- Recently received noice for
upcoming ministry audit
- Received a Warning Letter
from ministry of health
- Received non-conforming observations
from an external audit
Repharm consultants can assist
pharmaceutical companies in these situations. Since time is
critical, Repharm has created an emergency hotline, which
can provide you some initial assistance in understanding what
is going on and how to proceed.
You can also send us e-mail at email@example.com.
This initial consultation of up
to one hour will be done at no charge. After the first hour,
a fee will be discussed and approved. If you are not satisfied
with Repharm services, you may cancel at any time and pay
for only the time you used.
Given that specific situations will
vary from one client to another, below we have provided situations
that are representative of companies and situations, whrere
we can support our clients;
Situation #1 - Postpone
an MOH audit
The MOH just contacted you to let
you know that they intend to inspect you facility next week;
you are not sure why they are coming and if you would be able
to pass the inspection. If you get Repharm involved immediately,
Repharm may be able to get an extension for the upcoming audit.
Repharm will ask the MOH certain
questions to ascertain the MOH's objectives with their audit.
Based on the response of the MOH, we can help you to craft
a strategy to have the audit postponed or to prepare for the
Prior to the MOH audit, we can
conduct a mock MOH inspection and provide you with a list
of action items that have to be addressed, so you are better
prepared for the official visit. At your request, Repharm
can also be present during the MOH inspection to ensure that
the inspection proceeds properly and to assist in providing
immediate strategies for addressing problems that the MOH
Situation #2 - Respond
to an MOH Audit
The MOH just finished their inspection
and you just received the List of Observations from auditors
from Ministry of Health. This List of Observations contains
deviations that the MOH found during their visit.
Repharm will provide you with
an explanation of these deviations, what their implications
might be, and what regulatory actions the MOH may likely take
against your company (i.e. Warning Letters, Seizure, Injunction).
A proper response to all MOH observations
must be done within matter of days and must be written in
a specific manner to greatly reduce the likelihood of receiving
a Warning Letter in the future.
Situation #3 - Respond
to an MOH Warning Letter
The issuance of a Warning Letter
is a very serious violation and should not be taken lightly.
Your response to the Warning Letter has to be made in such
a way to provide a good understanding of the situation, but
it has to address the actions that your company has taken
or will take to assure compliance.
Repharm will provide you guidance
in reviewing the Warning Letter, determining what underlying
concerns there might be and provide a strategic plan on how
to respond to the letter. The decision to meet with the MOH,
at this time, may very well be warranted. These options, as
well as all others, could be discussed.