By not providing employees with any product info and personal protection
Apotex promoted products induced violence at work / antidepressant
nightmares. Withdrawal can often be more dangerous than continuing on a
medication. It is important to withdraw extremely slowly from these drugs,
usually over period of a year or more (conditions may not be reversible and
may last a life time-often damage is permanent), under the supervision of a
We did have on daily bases incidents/accidents and substantial product
As all Operators and other Personnel I got massive exposure to unidentified
product (s )- exposed to chemicals in processes.
Apotex, who exposes own employees to these extremely addictive drugs with
out any protection, with no warning of the addictive properties should be
held accountable for the results of that lack of warning and criminal
Company terrorized by many means any one / other employees voicing concerns
about issues with Safety, quality of the products and adverse side effects.
Employees worked with out any PPE/collective (Personal Protection Equipment)
and sustained sever injuries on daily bases. Apotex subjected me to the most
horrifying experiences imaginable. Withdrawal from these serotonergic
antidepressants, according to the World Health Organization, appears to be
even worse than the benzodiazaphines - which already have one of the worst
reputations for serious withdrawal.
Company did not provide First Aid materials and employees had to supply
themselves in "One dollar stores " with chip medical supply which on regular
bases were ending up processed in the products.
Apotex's EXECUTIVES DID COACHE EMPLOYEES TO PROVIDE FALSE INFORMATION TO
AUTHORITIES HPFBI - Health Products and Food Branch Inspectorate.
PAXIL ALONE - WE MANUFACTURED / PROCESSED, PACKAGED OVER 12 MILLION DOSAGES
of it EVERY 24 HOURS AND THAT WAS DONE DURING NUMBER OF YEARS OF VERY
SUBSTANTIAL EXPANSION / CONSTRUCTION, WHEN ALL PLANT WAS TURNED UP SIDE DOWN
AND ALL SYSTEMS / EQUIPMENT WERE INVALIDATED /NON OPERATIONAL!
SOP /GMP, SAFETY NON EXISTENT etc.
Executives were reviewing Documents requested by HPFBI to reassure that they
do not contain any info indicating non compliance with HPFBI
investigation/regulations (fabrication of Documentation).
Company criminally concealed names/ nature of processed products. Company
processed products with out regulatory permits in Facility not approved for
those products (not providing any personal protection for Personnel), did
not post Work Orders nor Safety Data Shits and did not disclose short and
long term health hazards do to massive unprotected exposures . All Operators
/Personnel displayed alarming level of problems with judgment/reasoning.
They did have dramatically decreased concern for safety (obliviousness).
Routinely displayed signs of Dementia, aggression, radicalism etc.
. Always they appeared more capable than (s/he) actually were
. Operators reported no difficulty in doing certain tasks, yet they were
unable to do them, or not be doing them.
. Due to massive and unprotected exposure to multitude of very potent
/restricted active ingredients combined with lack of prior
pharmaceutical/technical experience their specific skills deteriorated at
different rates affecting different abilities. This resulted in them being
able to do in limited manner some steps in a task but not others. Operator's
denial of the decrease in abilities was common and in results dangerous).
I am dying every day in excruciating pains.
The type/variety of my pains are countless and in manifestation horrifying.
I have cluster of symptoms, and there is no definitive cure. This is
tremendously frustrating to physicians and that means, I AS A PATIENT DO
Apotex (with accomplices) denied me medical help, deprived me of all means
of sustaining myself and is not regretful. Imposed on me poverty, immense
stress and obstacles etc.
Those issues amongst other were neglected:
The holder of an establishment licence, or any operation to which the
requirements of Division 2 are applicable, must ensure that the fabrication,
packaging, labelling, distribution, testing, and wholesaling of drugs comply
with the requirements of the marketing authorization and do not place
consumers at risk due to inadequate safety and quality. The attainment of
this quality objective is the responsibility of senior management and
requires the participation and commitment of personnel in many different
departments and at all levels within the establishment and its suppliers. To
achieve the objective reliably, there must be a comprehensively designed and
correctly implemented system of quality assurance that incorporates Good
Manufacturing Practices and thus quality control. The system should be
fullydocumented and its effectiveness monitored. All parts of the quality
assurance systems should be adequately resourced with qualified personnel,
suitable premises, equipment, and facilities. There are additional
legislative responsibilities for the holder of the establishment licence
and for the person(s) authorized to market drug products.
The basic concepts of quality assurance, Good Manufacturing Practices and
quality control are interrelated.
They are described here in order to emphasize their relationships and their
importance to the production and control of drugs.
Quality assurance is a wide-ranging concept that covers all matters that
individually or collectively influence the quality of a drug. It is the
total of the organized arrangements made with the objective of ensuring that
drugs are of the quality required for their intended use. Quality assurance
therefore incorporates Good Manufacturing Practices, along with other
factors that are outside the scope of these guidelines.
A system of quality assurance appropriate for the manufacture of drugs
should ensure that:
1. Drugs are designed and developed in a way that takes into account the GMP
2. Managerial responsibilities are clearly specified;
3. Systems, facilities and procedures are adequate;
4. Production and control operations are clearly specified, and GMP are
5. Arrangements are made for the supply and use of the correct raw and
6. Control on intermediates, in-process monitoring, and validation
activities are carried out;
7. The finished product is processed, packaged/labelled, verified, and
tested according to
8. Drugs are not sold or supplied before the quality control department has
indicated that each batch has been produced and controlled in accordance
with the requirements of the marketing authorization and of any other
regulations relevant to the production, control and release of drugs;
9. Satisfactory arrangements exist for ensuring that the drugs are stored,
subsequently handled in such a way that quality is maintained throughout
their shelf life;
10. There is a procedure for self-inspection and/or quality audit that
regularly appraises the effectiveness and applicability of the quality
GOOD MANUFACTURING PRACTICES (GMP) FOR DRUGS
Good Manufacturing Practices (GMP) are the part of quality assurance that
ensures that drugs are consistently produced and controlled in such a way to
meet the quality standards appropriate to their intended use, as required by
the marketing authorization.
GMP are concerned with both production and quality control. Their basic
requirements are as follows:
1. Manufacturing processes are clearly defined and controlled. All critical
validated to ensure consistency and compliance with specifications.
2. Manufacturing processes are controlled, and any changes to the process
Changes that have an impact on the quality of the drug are validated as
3. All necessary key elements for GMP are provided, including the following:
- qualified and trained personnel
- adequate premises and space
- suitable equipment and services
- correct materials, containers and labels
- approved procedures and instructions
- suitable storage and transport
4. Instructions and procedures are written in clear and unambiguous
5. Operators are trained to carry out and document procedures;
6. Records are made, manually or by instruments, during manufacture that
demonstrate that all the steps required by the defined procedures and
instructions were in fact taken and that the quantity and quality of the
drug was as expected. Deviations are investigated and documented;
7. Records of manufacture (including distribution) that enable the complete
history of a batch to be traced are retained in a comprehensible and
8. The distribution of the drugs minimizes any risk to their quality;
9. A system is available for recalling any batch of drug from sale or
10. Complaints about marketed drugs are examined, the causes of quality
investigated, and appropriate measures are taken with respect to the
defective drugs and to prevent recurrence.
Quality control is the part of GMP that is concerned with sampling,
specifications, testing, documentation and release procedures. This approach
ensures that materials are not released for use, and that drugs released for
sale or supply, until their quality has been deemed satisfactory.
The basic requirements of quality control are as follows:
1. Adequate facilities, trained personnel, and approved procedures are
available for sampling, inspecting and testing of raw materials, packaging
materials, intermediate bulk and finished products, and, where appropriate
monitoring environmental conditions for GMP purposes;
1.1 Samples of raw materials, packaging materials, and intermediate, bulk,
products are taken according to procedures approved by the quality control
1.2 Test methods are validated;
1.3 Records are made that demonstrate that all the required sampling,
testing procedures were actually carried out, and any deviations are
1.4 The finished products contain active ingredients that comply with the
quantitative composition requirements of the marketing authorization, have
required, are enclosed within their proper container and are correctly
1.5 Records are made of the results of inspection, and to show that testing
and of intermediate, bulk, and finished products is formally assessed
1.6 Product assessment includes a review and evaluation of relevant
documentation and an assessment of deviations from specified procedures;
1.7 No batch of drug is released for sale or supply prior to approval by the
department, in accordance with the requirements of the marketing
(Notice of Compliance (NOC), Drug Identification Number (DIN));
1.8 Sufficient reference samples of raw materials and drugs are retained to
examination of the drug if necessary, and the drug is retained in its final
exceptionally large packs are produced.
ACTIVE PHARMACEUTICAL INGREDIENT(ingrédient pharmaceutique actif) - Any
substance or mixture of substances that is intended to be used in the
manufacture of a drug (medicinal) product and that, when used in the
production of a drug, becomes an active ingredient of the drug product. Such
substances are intended to furnish pharmacological activity or other direct
effect in the diagnosis, cure, mitigation, treatment, or prevention of
disease or to affect the structure and function of the body. (ICH, Q7A, step
BATCH (lot de fabrication) - A quantity of drug in dosage form, a raw
material, or a
packaging material, homogeneous within specified limits, produced according
to a single production order and as attested by the signatories to the
order. In the case of continuous manufacture, a batch corresponds to a
defined fraction of the production, that is characterized by its intended
homogeneity. It may sometimes be necessary to divide a batch into a number
of sub-batches, which are later brought together to form a final homogeneous
BATCH CERTIFICATE (certificat de lot) - A certificate issued by the
fabricator of a lot or batch of a drug that is exported within the framework
of a mutual recognition agreement and in which the fabricator
(a) identifies the master production document for the drug and certifies
that the lot or batch has been fabricated, packaged/labelled and tested in
with the procedures described in that document;
(b) provides a detailed description of the drug, including
(i) a statement of all properties and qualities of the drug, including the
identity, potency and purity of the drug, and
(ii) a statement of tolerances for the properties and qualities of the drug;
(C) identifies the analytical methods used in testing the lot or batch and
details of the analytical results obtained;
(d) sets out the addresses of the buildings at which the lot or batch was
fabricated, packaged/labelled and tested; and
(e) certifies that the lot or batch was fabricated, packaged/labelled and
in accordance with the good manufacturing practices of the regulatory
authority that has recognized those buildings as meeting its good
manufacturing practices standard. (C.01A.001)
BATCH NUMBER (numéro de lot de fabrication) - A distinctive combination of
and/or letters that specifically identifies a batch. The batch number
appears on the batch
records, certificates of analysis, etc.
BRACKETING (méthode des extrêmes) - The design of a stability schedule such
that only samples on the extremes of certain design factors (e.g., strength,
package size) are tested at all time points as in a full design. The design
assumes that the stability of any intermediate levels is represented by the
stability of the extremes tested. Where a range of strengths is to be
tested, bracketing is applicable if the strengths are identical or very
closely related in composition (e.g., for a tablet range made with different
compression weights of a similar basic granulation, or a capsule range made
by filling different plug fill weights of the same basic composition into
different sized capsule shells). Bracketing can be applied to different
container sizes or to different fills in the same container closure system.
BULKDRUG(drogue en vrac) - Unpackaged dosage form, usually in quantities
larger than the largest commercially available package size.
CERTIFICATE OFMANUFACTURE(certificat de fabrication) - A document issued by
a vendor to a distributor or importer that attests that a specific lot or
batch of drug has been produced in accordance with its master production
document. Such certificates include a detailed summary of current batch
documentation, with reference to respective dates of revision, manufacture,
and packaging, and are signed and dated by the vendor's quality control
CHANGE CONTROL(contrôle des changements) -Awritten procedure that describes
the action to be taken if a change is proposed (a) to facilities, materials,
equipment, and/or processes used in the fabrication, packaging, and testing
of drugs, or (b) that may affect the operation of the quality or support
CHANGE OVERPROCEDURE (procédure de conversion) - A logical series of
validated steps that ensures the proper cleaning of suites and equipment
before the processing of a different product begins.
CLEAN AREA(aire propre) -Aroom or suite of rooms where GradeC orDconditions
table in Section C.02.029 of these guidelines) are required. The rooms have
environmental control of particulate and microbial contamination and are
maintained, and used in such a wayas to minimize the introduction,
generation, and retention of contaminants.
CRITICAL PROCESS (procédé critique) - A process that may cause significant
variation in the quality of the finished product.
DATE OF FABRICATION (date de fabrication) - Unless otherwise defined in the
and Drug Regulations, this is the date when any active ingredient,
or air/oxygen scavenger is first added to the lot being processed.
"Yet who Knows the Truth and Calls it a Lie, is a Criminal."
Well, I have to give to Apotex a credit for flexibility and adaptability.
THIS IS VERY STRONG SIDE OF THIS COMPANY!
I ADMIRED CEO Dr. Bernard Sherman and Jack Kay, President & COO of Apotex
FOR IT FOR MANY YEARS.
Recently again Apotex was ravaged /compromised by scandals of notorious
contamination / non compliance and now it does what they do the best- do
what ever it takes to bit the system and by strategic move reviews portfolio
of 300 products.
Scandals with routine quality /contamination issues of large number of own
label products, APOTEX overcomes with a brilliant strategic move. Now will
cash on sale of more than 40 pharmaceutical products to AA Pharma and will
continue to do the production of these products in Facilities
blamed/notorious for contamination / non compliance.
These products represent important / different therapeutic categories and
the sale takes effect as of August 3rd, 2010.
AA Pharma will immediately start selling these products and the Apotex label
will be transitioned to the new name over a period of time so the
Authorities and CUSTOMERS will be led to think, that they are using new
Personally as a former employee of this organization I wish Apotex all
success in recovery process and hope that Apotex can have corporate dignity
to step up to its obligations and compensate its "victims" for corporate