Quality Process in the Purification of Drinking Water in 12 Steps
(c) Nestle Waters
The process aims to guarantee the highest safety standards for
drinking water and ensure a taste that is in accordance with consumer
preference.
Water is carefully collected and received through stainless
steel pipes from either a local well or municipal water supply. Quality
testing of the original source is conducted regularly to monitor for
abnormalities.
This step is taken when the water originates from a municipal or
public drinking water system. It consists of removing chlorines and
THMs (trihalomethanes) through a daily-monitored activated carbon
filtration process.
A water softener is used to reduce water hardness.
Demineralisation removes unwanted minerals (through reverse osmosis or distillation).
Water received in storage tanks is monitored on a daily basis.
Selected minerals are added to cater to consumer taste preferences.
Pharmaceutical grade micro-filtration removes particles as small
as 0.2 microns. It is also capable of removing potential
microbiological contaminants. This is monitored on an hourly basis.
Ultra-violet filtration provides additional product disinfection. This is monitored on an hourly basis.
Ozone disinfection is the third disinfection step (steps 7-9),
using a highly reactive form of oxygen. This is monitored on an hourly
basis.
The filling room is highly sanitary to ensure bottling is
conducted in a microbiologically controlled environment. It is
continuously monitored and controlled.
Packaging quality assurance is conducted by human inspection and
the latest in modern equipment designed to ensure the removal of any
packaging defects.
Line sanitation includes automated cleaning equipment to ensure maximum cleanliness, effectiveness and control.
Objective
:To
describe a procedure for handling of deviations which may occur during the
execution of various activities in written procedures in facility.
Scope:This Standard Operating
Procedure shall be applicable to all the departments responsible for
carrying activities related to the manufacture of the product, in the
formulation plant of (Pharmaceutical Company Name).
Responsibility
Personnel
of concerned department shall be responsible to notify immediately their
respective superiors when any deviation occurs or is noticed.
Head-Regulatory
Affairs or his/her designee shall be responsible for facilitating prior
notification or intimation to the regulatory authority, if the deviation
has impact on the concerned regulatory submissions.
Head
of the concerned department or his/her designee, and Head-Quality
Assurance or his/her designee of respective location shall be responsible
for implementation and compliance of this SOP.
Accountability
4.1 QA Head shall be
accountable for implementation of this SOP.
Abbreviations and Definitions
BMR:Batch manufacturing
record; a controlled regulated copy, which comprises the recordings against the
manufacture of a batch.
PDR :Planned deviation
report
UDR :Unplanned deviation
report
cGMP:Current good
manufacturing practices
BPR:Batch packing record
ICH:International
conference on harmonization
Written Procedures :Written
procedures are the approved and controlled documents which are followed for the
execution of various activities performed in the organization viz.,Batch
Manufacturing Records detailing manufacturing and packaging procedures,
Standard Operating Procedures (SOPs), Standard Testing Procedures (STPs).
General Test Procedures and various protocols followed for the execution of
validation studies, stability studies, etc.
Deviation : Any non-conformance
/disobeyance in written approved procedures of quality system in the
organization.
Or
We have any written
procedure like standard operating procedure, standard test
procedure, BMR etc. and works against this, then it is called deviation. It
means deviation from any written procedure that we have implemented.
Critical Deviation: The
deviation is likely to or will have a significant impact on critical attributes
of the product.
For example: Manufacturing
instructions are not followed, wrong batch details are printed,
SOPs or methods
of testing not followed during analysis etc.
Major Deviation : The
deviation could or may have a significant impact on critical attributes of the product.
For example: Raw material is
received in a damaged container, manometer readings in the
sampling booth are crossed the action limits etc.
Minor Deviation:The
deviation is unlikely to have a detectable impact on critical attributes of the
product.
For example: Line Clearance is not taken
from QA, physician sample wrongly printed with price, etc.
Critical Attribute :A
critical attribute is one that defines the product and contributes to safety, identity,
purity, strength or quality. Critical attributes are usually
detectable during product testing.
Unplanned Deviation: An accidental
or unanticipated
non-conformance or deviation observed or noticed during or
after the execution of an activity. An unplanned deviation can be
a critical or major or minor in nature.
For example: deviation in
failure of procedure, utility, material, equipment or any system is occurred.
We can consider it as any change from the previous or our written procedure.
Planned Deviation : Any
deliberate or intentional non-conformance or deviation Planned prior to
the execution of an activity, which is to be undertaken following documented,
justifiable and approved rationale. No critical or major deviation, which has potential
to alter the quality of the product, shall be planned.
For example: Calibration or
validation is not carried out as per schedule due to delay for various reasons.
Procedure
Deviations
may be classified into following two categories:
Planned
Deviation
Un-planned
Deviation
Unplanned & Planned
deviations shall be sub classified on the basis of their impact of product
quality in critical, major or minor.
Planned
Deviation (Planned Deviation Report)
Any
departure from established and approved procedures observed or noticed
prior to the execution of an activity, such as SOPs, STPs, processes,
systems, standards and protocols, which is done under compulsion or for
continuous quality improvement programs will be categorized as planned
deviation.
No
critical or major planned deviation shall be allowed, which has potential
to alter the quality of the product, only minor deviation shall allow to
plan.
Such
a planned deviation shall be taken / implemented only after proper
evaluation, risk assessment and pre-approval from Quality Assurance.
Such
planned deviation shall be properly reported, assessed / evaluated for
its impact on product quality, process performance or GMPs.
Any
personnel from concerned department shall initiate the “Planned Deviation
Format” by detailing the reason for deviation as per Annexure I.
The
department head shall review the proposal of planned deviation,
justification given for its potential impact on the product quality and
compliance to regulatory requirements for necessity / feasibility of the
deviation, by providing supporting data.
After
review by concerned Head of department, the proposal shall be forwarded
to Plant Head.
After
review by Plant Head, the proposal shall be forwarded to QA for review
and approval.
QA
shall assign a unique number to each planned deviation as follows:
The
numbering system for a planned deviation shall consist of ten (10)
alphanumeric characters.
For
example, PDR/16/001 shall be assigned to the first planned deviation of
year 2016.
In
the above planned deviation report number, the 1st, 2nd & 3rd
characters ‘PDR’ stand for ‘Planned Deviation Report’.
The
4th character “/” is a forward slash.
The
5th & 6th characters ‘16’ represent the last two digits of the year
2016.
The
7th character “/” is again a forward slash.
The
8th, 9th & 10th characters ‘001’ represent sequential number.
Head
QA shall review the planned deviation with respect to impact on product
quality, necessity / feasibility of the deviation proposed, rationale /
justification & compliance to cGMP / regulatory requirements, along
with the adequacy of the supporting data attached.
Head
QA shall assess the requirement for any additional testing or checks for
quality monitoring of the Planned Deviation and documents for the same.
QA
shall consult Regulatory Affairs, where applicable, for any planned
deviation before providing approval. The RA may provide inputs as
necessary based on GMP and regulatory requirements.
Head
QA shall approve / reject the Planned Deviation with appropriate
recommendations.
If
approved, the deviation shall be applicable for a defined number of batch
(es) or defined number of days as mentioned in the Planned Deviation
Report.
After
QA approval, the concerned department shall implement the planned
deviation and the observations and data generated shall be documented.
QA
shall review the implementation and documented data obtained from
respective departments to ensure that the recommendations are complying
with quality profile of the batch (es) impacted by the deviation. This
data shall support with the “Planned Deviation Report”.
The
closure of planned deviation shall be the responsibility of the
Department Head and Head-QA.
If
the deviation is related to the batch which is for sale, then the batch
shall be released only after QA approval and closure of deviation.
Recommendations
may be conferred during the review.
If
the planned deviation in the process / procedures leads to improvement in
the product quality / process / assurance / GMP, then the deviation / change
can be made permanent by following the change control procedure (SOP on
change control procedure).
In
conclusion, Head of concerned department and Head QA shall close out the
deviation.
QA
shall maintain a logbook for the approved planned deviations as per
Annexure III.
Unplanned
Deviation (Unplanned
Deviation Report)
While
carrying out day-to-day activities, there is a probability of unplanned
deviations (unforeseen deviations) occurring. Such unexpected events may
be related to any procedures, processes, systems, equipment and
utilities. These deviations may occur for many reasons, such as following
(not all inclusive):
Equipment
failure / Breakdown / Malfunctioning.
Power
supply failure / interruption.
Accident
in the plant.
Breakdown
in support services / utilities.
Documentation
Errors
Laboratory
failure / Error.
An
unplanned deviation report (UDR) shall be initiated as a part of the
approved system for handling of deviations, in order to provide a
mechanism for ensuring the recording of the deviation and assess the
impact on product quality. If required, corrective and preventive action
shall be performed to ensure product quality.
User
department shall make request for issuance of unplanned deviation Format
to Quality Assurance department through Issuance from.
Any
individual on the job shall inform concerned department supervisor
regarding the occurrence of deviation and details of initial observations.
The
concerned department personnel shall fill the details of the unplanned
deviation along with cause and investigation details as per Annexure II
and forward the same to department head for review, assessment and
comments.
While
review, concerned head of the department shall incorporate corrective and
preventive action based on assessment. Then the ‘Unplanned Deviation
Report’ shall be forwarded to Plant Head for review.
Then
‘Unplanned Deviation Report’shall be submitted to the QA for review and
approval.
QA
shall assign a unique number to each unplanned deviation report as
follows;
The
reference number for an unplanned deviation report shall consist of ten
(10) alphanumeric characters.
For
example, UDR/16/001 shall be assigned to the first unplanned deviation of
year 2016.
In
the above unplanned deviation report number, the 1st, 2nd & 3rd
characters ‘UDR’ stands for ‘Unplanned Deviation Report’.
The
4th character “/” is a forward slash.
The
5th & 6th characters ‘16’ represent the last two digits of the year
2016.
The
7th character “/” is again a forward slash.
The
8th, 9th & 10th characters ‘001’ are a sequential number.
QA
shall maintain a logbook for the unplanned deviations as per Annexure
III.
The
filled form shall be forwarded to QA head after review by QA.
Head
– QA & Head – concerned department shall assess unplanned deviation
for its impact on product quality. Details shall be documented as per
Annexure II.
Head
QA may recommend for performing any additional studies, if required.
If
the deviation does not affect product quality, Head – QA shall allow
further processing of the batch in question.
If
there is probability of product quality getting affected, Head – QA shall
assess the impact on product quality before allowing further processing
of the batch.
Product
may be “Quarantined” in sealed containers, if required. Containers shall
be labeled, indicating product name, Batch No., Manufacturing Date,
Expiry Date & Batch size. The labeled containers shall be kept in
secured quarantine area.
Head
– QA along with the Head of concerned department shall investigate &
find out the root cause of the problem that resulted in the deviation as
per SOP on CAPA.
Based
on the investigation, the proposed corrective and preventive action shall
be taken to avoid any such reoccurrence and the same shall be
implemented.
If
required Formulation Research & Development (FR&D) shall be
consulted by QA to review impact on product quality and decide upon the
future course of action(s).
Closure
of Deviation
In
conclusion, Head – QA shall close the deviation by reviewing and assessing
the impact of deviation on the quality of the product.
Any
supporting data and comments required to close the deviation
(e.g.stability data) shall be recorded or attached to the deviation
report.
The
time line for closure of deviation (planned or un-planned) shall be not
more than 30 working days. If required, extension should be taken.
Both
planned and unplanned approved deviations shall be controlled by QA and
the same shall be documented in the respective BMR also.
(Note:
The planned deviation shall be implemented after
the approval of QA).
Forms
and Records (Annexures)
Planned
Deviation Report – Annexure-I
Unplanned
Deviation Report – Annexure-II
Logbook
for Planned/Unplanned Deviation Reports – Annexure-III
