| QUALITY
ASSURANCE |
ADAMS
has adopted and documented a quality policy;
I.E. "We begin everything with quality, ensure
quality in every process to obtain excellent outputs that
meet regulatory requirements and customer satisfaction".
In pursuit of our quality policy the company has established
a quality management system in accordance with the requirements of gmp.The quality management
system is implemented and maintained as specified in the company's standard
operating procedures (sop) manual. The effectiveness of
the quality management system is continuously improved
through self inspections/internal quality audits, regular
management reviews and as a result of corrective and preventive
actions.
The processes needed to effectively carry out the activities
of the company are identified to ensure ongoing customer
satisfaction.
Management ensures that the resources and the information
needed to carry out these processes are made available.
These processes are monitored and prescribed measurements
are carried out.
PERSONNEL TRAINING
All new employees engaged in sections of the company whose
activity has a bearing on product quality are taken through
a basic training on GMP.
DOCUMENTATION
The documentation of activities affecting product quality
is based on a consistent set of documents that include:
•Documented
standard operating procedures (sop's) and associated forms
•Technical production
documents
•other documents
required for gmp compliance and required to meet statutory
requirements
QUALITY CONTROL
Quality control activities including sampling, testing,
required documentation and records, and release procedures
are established to ensure that the necessary and relevant
tests are actually carried out and that materials are
not released for use, no products released for sale or
supply, until their quality has been judged to be satisfactory.
Products are tested at various stages as specified in
the quality plans. test specifications specify the acceptance
criteria.
The monitoring activities also include a review and evaluation
of the relevant production documentation and an assessment
of deviations from specified procedures if any.
No batch of product is released for sale or supply unless
certified by the authorized person(s) that all the requirements
are met and that it is in accordance with the requirements
of the marketing authorization. |
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