Below are the responsibilities of Engineering personnel in Pharmaceutical Industry (But not limited To)
|1. To follow Good Engineering Practice.|
|2.Preparation and Review of departmental SOPs|
|3. Preparation and Review of PM schedule, checklist and attending breakdown.|
|4. Observation and Guideline in installation activities of new equipment’s or projects at site.|
|5. Implementation of SAP|
|6. To review and undertake audits of vendor quality management system.|
|7. Review and implementation of Technical Agreement.|
|8. New vendor developments for different engineering services and follow up.|
|9.To witness calibration and validation activities and review of calibration certificates.|
|10. Support in installation activities of equipment’s.|
|11. Validation and Review of Site master plan and Coordination with contract persons|
|12.Preparing all drawings and related system engineering documents, such as :|
|P & I drawings|
|Utility drawing such as HVAC, Water system|
|Building and Room Drawings|
|Equipment Component Identification|
|Identification of Calibration Requirements|
|Equipment Installation and System Construction Procedures.|
|13. Co-ordination of the calibration activities for all critical instruments as identified by the validation team.|
|14. Executing, Installation Qualification and Operational Qualification tasks and assisting in the execution of Performance Qualification.|
|15. Maintenance of process & utility equipment.|
|16. Responsible for handling of change control, deviation, and incidents within the department.|
|17. To ensure the ALCOA Data Integrity Checks.|
Annex 11 requires that audit trails are regularly reviewed to ensure data integrity. There are a significant amount of inconsistent interpretations about the requirement to regularly review audit trails. Some of the interpretations are that a periodic review of audit trails should be performed to ensure data integrity. Under a periodic review approach some companies have implemented a monthly, quarterly, bi-annual and yearly review of audit trails. The challenge is how relevant it is to perform a periodic review after an extended period of time when the data was generated. What is the value? What are we supposed to be looking for? What constitutes a data integrity issue? Which data is critical? Should we take a risk based approach?
This article will provide answers to these challenging questions and solutions about how to perform regularly audit trail reviews.
The Challenges :
Aligning with the requirement to regularly perform audit trails reviews can be very challenging for some companies. This requirement is based on the assumption that all system provide audit trails that are “user friendly”, adequate and easy to review for data integrity. One of the biggest challenges is that some systems specifically in the Quality Control laboratories don’t generate audit trails that facilitate a review regularly. Another challenge is whether to perform periodic review or to assess the audit trails prior to signing or approving the data. Can we implement the same approach for all areas with GMP impact or can we take a risk based approach. Which approaches are more value added and not just a paper work exercise?
Unfortunately Annex 11 and other data integrity philosophies fail to provide adequate guidance and direction about how to regularly review audit trails. There is always the challenge on how to deal with all the assumptions related to this requirement and this also includes resources to regularly review audit trails. In order to review audit trails regularly qualified resources are needed to perform this work. The resource impact needs to be clearly understood based on the population of impacted systems, the volume of the reviews and the defined frequency. All the potential challenges need to be well understood and addressed prior to committing to perform audit trails reviews, otherwise the effort will be meaningless and simply a paper exercise.
Audit Trail Assessments :
In order to align with the requirement to regularly review audit trails an assessment needs to be performed for all impacted systems. The audit trail assessment is the first and the most critical steps to implement audit trail reviews. An inventory of all impacted systems need to be created. This inventory will identify all impacted systems that need to be included in the audit trail assessment. The intent of the assessment is to identify whether each individual system provide audit trails that are adequate and that can be used for performing these reviews.
System level risk assessments need to be performed to identify whether the system is high, medium or low risk. The system risk needs to be used to prioritize the audit trail assessment and implementation of periodic reviews. For example a quality control system to measure critical quality attributes is probably high risk and should be a priority. A risk based approach will be discussed in more detail later in this article.
Each functional area that have GxP computer systems need to perform the audit trail assessment to determine the following:
- Who has access to view the audit trails?
- Can the audit trail be printed from the application?
- Can the reviewer select a data range?
- Can the reviewer select a specific activity of interest during the audit trail review?
- Will it feasible to include the audit trail with the data results?
- Will it be feasible for QC systems to include the audit trail with the assay results?
- Are user’s action time and date stamped?
- Does the audit trail records creation, modification and deletion of records?
The answer to each question will be potentially being different for each system assessed. Based on the results of this assessment remediation activities may be required to address any gaps or improvements need for audit trails.
To document the results of the audit trail assessment a summary report should be created to summarize the findings.
A remediation plan should be created to describe the corrective actions that will be taken for each system.
Once all remediation activities are closed procedures need to be created or revised to include the steps for performing audit trails periodic review.
Risk based Approach :
A risk based approach to audit trail reviews is critical for an implementation that provide a meaningful process without having a negative impact on cost and resources. The fact is that without taking a risk based approach audit trail reviews can have a negative impact on cost and resources. Audit trail reviews for GxP systems are a time consuming activity that requires resources to execute and manage the information an actions related to the review.
In order to take a risk based approach to audit trail reviews the system risk level need to be identified. Prioritizing the audit trail assessment based on the level of risk is critical to prioritize the assessments and implementation. Systems involved in the testing of Critical Quality Attributes are high risk and should be the highest priority during the assessments and implementation.
The system risk level should be used to establish the frequency and scope of the audit trails periodic reviews. For high risk systems such as those used in Quality Control the audit trails should be reviewed with the test results to ensure the integrity of the test data. The scope of this review should include assessing the accuracy and integrity of the data using the audit trail. In this situation the audit trail will be reviewed for the following:
- Changes to test parameters
- Changes to data processing parameters
- Data deletion
- Data modifications
- Analyst actions
- Data manipulation
- Excessive integration of chromatography peaks
- Security breaches related to data
QC procedures need to define the controls related to data integrity; this will ensure consistency during the audit trail review.
For medium and low risk systems the approach will be less intensive that for high risk. For these systems it can be possible to review periodically the audit trails. The periodic review period should be established based on the level of system risk. Medium risk systems should be reviewed more frequently than low risk systems. For example a document management system is probably medium risk that should be on a periodic review schedule of every six months or a yearly schedule. Low risk system can be reviewed on a yearly or bi-annual basis.
The scope of the audit trail reviews for medium and low risk systems should include the following:
- Data changes
- Data deletions
- Unauthorized access or transactions
To implement audit trail reviews is critical to take a risk based approach. A one size fits all approach can have a significant impact on cost and resources.
In summary a risk based approach is critical for the implementation of audit trail periodic reviews.
Once the audit trail assessment are performed, system risk identified and all corrective actions are closed the audit trail reviews can be implemented. Prior to implementation the impact to resource need to be well understood based on the expected volume of work. Once this impact is understood hiring and reassigning of resource need to be completed prior to formal implementation.
Procedure may need to be created or revised to include the approach of audit trails reviews for each system based on the results of the assessment and system risk.
The last step is training all impacted resources on the applicable procedures with an emphasis of data integrity.
Annex 11 requires that audit trails are reviewed regularly to ensure data integrity. The frequency and scope of the audit trail reviews is not defined in annex 11. Audit trails periodic reviews have impact on resources and cost. To minimize the cost and resource impact and risk based approach should be taken for the implementation of audit trails review. The approach should be based on the system risk level which will facilitate defining scope and frequency of the reviews.
An audit trail review when properly implemented can increase the integrity of data generated by GxP systems.
- To laydown a procedure for the cleaning, storage, usage and maintenance of packing machine change parts.
- Technical Assistant – Cleaning/storage/Maintenance of packing machine change Parts.
- Executive – Responsible for Cleaning/storage/Maintenance of packing machine change parts.
3.1.1 Dismantle the change parts from the machine.
3.1.2 Clean the change parts, using lint free dry cloth.
3.1.3 Check the change parts removed from the machine and keep the change parts in the rack provided.
3.1.4 Affix a cleaned label to the change parts.
3.1.5 Clean and lubricate the change gears.
3.1.6 Clean other parts with lint free cloth.
3.1.7 Frequency of cleaning for all the change parts which comes into contact with the product – For every three batches (of similar products), or after every batch (for different products), or weekly (if machine is in operation) or monthly (if machine is idle) which ever is the earlier and as and when required.
3.1.8 Frequency of cleaning the change parts, which do not come into contact with the product – after every product change over or every month if machine is idle.
At all times when not in use the change parts shall be stored in racks duly identified.
NOTE: Handle all the change parts carefully during assembling and dismantling.
Size changeover is always done after complete dismantling of the change parts previously used.
Assemble all the change parts after cleaning of the machine.
Incoming inspection – Engineering department shall receive the change parts from the supplier and subject them to the inspection. Any sets not conforming to the specifications are returned to the supplier for the replacement.
On receipt of the change parts into the department the production personnel shall inspect the parts, identify them with the appropriate number.
If any damage occurs to the change parts it should be immediately intimated to the maintenance department for corrective action.
Record the details in change parts record
Precautions: Take care that critical parts like blow head, counter-sealing roller of Blister packing machine, sealing rollers of strip packing machine, punching tool, embossing tools are kept in safe area.
Collect properly the embossing rollers & keep them in safe area.
Change parts record
1.1 To lay down a procedure for Preventive Maintenance of Auto Coater.
- All Tec. Assistants – To perform the preventive maintenance activities as per the respective SOP.
- All Executives (Eng.Dept.) – To prepare and comply the preventive maintenance SOP.
- All Department Heads – To implement and compliance of this SOP.
3.1 Weekly Maintenance
- Check all contactors and tighten the line connections.
- Check all solenoid valves and coils for proper working.
- Check the working of all PLC interlocks.
- Check the tightness of all fasteners, if required tighten all fasteners.
- Check for air leakages from PU tube and connectors, if found arrest the same.
- Check the working of steam trap, inlet air handling unit and dehumidifier.
- Check the working of steam control valve by changing the inlet set temperature values, if required repair / replace the control valve.
3.2 Monthly Maintenance
- Check the oil level in the gear box, if required refill with fresh oil up to the mark.
- Check the pan supporting wheel bearings, if required lubricate the bearings.
- Check the v-belt/chain tension, if required replace or adjust the v-belt/chain tension. (Wherever applicable)
- Clean the AHU pre filters and scrubber unit filters (wherever applicable) and scrubber unit chamber.
- Check the working of inlet and exhaust dampers and its solenoid valves, if required repair or replace it.
- Check the pneumatic actuators working condition and leakages, if required replace the gasket of the actuators.
- Check the gun bar pneumatic cylinder alignment, if required re-align the alignments and check the movement of the cylinder shaft.
- Check the working of steam control solenoid valves.
- Check the functioning of all inter locks.
- Check the working of compressor and its interlocks.(Wherever applicable)
- Clean the condenser coil, chilled water/evaporator coil and wet scrubber unit with water. (Wherever applicable)
- Check the working of condenser fan and its inter connections. (wherever applicable)
- Check the working of dehumidifier bed drive, if required clean the bed by passing the compressed air at 1kg/cm² from the reverse direction of air flow.
- Check the working of dehumidifier heaters, if required replace with new heater.
3.3 Yearly Maintenance
- Check the motor bearings condition, if required replace with new bearings.
- Drain the gear box oil and top up with fresh oil up to the mark.
- Check the condition of steam coil, if any leakages observed arrest them.
- Check the inlet and exhaust blowers working and clean, if required.
- Check the scrubber unit filters condition, if required replace with new filters.(Wherever applicable)
- Check the condition of HEPA filter for physical damage and integrity, if required replace the filter with new one.
- Check the steam control valves for proper functioning, if required replace the valves with new one.
- Check the condition of all gaskets and replace all gaskets once in year.
- Check the condition of dehumidifier bed, if required replace with new bed.
- 4. ABBREVIATIONS
- SOP :- Standard Operating Procedure
- AHU :- Air Handling Unit
- PU :- Poly Urethane
- PLC :- Programmable Logic Control
- HEPA:- High Efficiency Particulate Air
- 5. REFERENCES
5.1 SOP: Procedure for preventive maintenance
- 6. ANNEXURES
Annexure – 1 Weekly preventive maintenance checklist
Annexure – 2 Monthly preventive maintenance checklist
Annexure – 3 Yearly preventive maintenance checklist
Annexure – 4 List of lubrication points and safety controls
1.1 To lay down the procedure for Preventive Maintenance of Autoclave
- Assistant – Engineering &Production – To follow the SOP
- Executive – Engineering & Production – To comply the SOP
3.1 Monthly Maintenance
3.1.1 Check the Oil level in the FRL unit assembly and refill the oil with in the limits.
3.1.2 Check all electrical connections in the panel if required tight all screw fastenings
3.1.3 Check the steam traps for proper working, if not replace with new one.
3.1.4 Check the Air leakages from all PU connectors and PU tubes.
3.1.5 Check the functioning of all solenoid valves, if it is not working properly clean the coil and plunger unit or replace the Coil.
3.1.6 Lubricate the synthetic grease to guide track of the door.
3.1.7 Check the leakages from the door gaskets, valves and from all joints.
3.2 Half Yearly Maintenance
3.2.1 Check the Solenoid valves and coils, clean the valves and if require replace the Coils
3.2.2 Check the Pneumatic cylinder seal kits if required replace the seals with new seals
3.2.3 Check the condition of Pneumatic actuators, if required replace with new one.
3.2.4 Check the actuator gaskets for leakages, if require replace with the new gaskets
3.2.5 Check the steam valves for leakages, if require replace the gaskets
3.2.6 Check the gland rope or mechanical seals of the WRVP for leakages if required replace the new gland ropes or Mechanical seals
3.2.7 Check the door Gaskets condition if require replace the with the new gaskets.
3.3 Yearly maintenance
3.3.1 Check the vacuum pump and motor bearings, if required replace the bearings.
3.3.2 Check the water leakage from the pump, if required replace the gland rope or mechanical seals
3.3.3 Check the safety valves working condition.
- FRL : FILTER REGULATOR AND LUBRICATOR
- WRVP : WATER RING VACUUM PUMP
- HPHV : HIGH PRESSURE HIGH VACUUM
- Annexure – 1 Monthly Preventive maintenance check lists
- Annexure – 2 Half yearly preventive maintenance check lists
- Annexure – 3 Yearly preventive maintenance check lists
- To lay down a procedure for Preventive Maintenance of Roll Compactor
- Assistant – Engineering – To follow the SOP
- Executive – Engineering – To Comply the SOP
- Weekly Maintenance
- Check the Hydraulic cylinder of augur lifter for proper working and oil leakages.
- Check the oil level in the main motor reduction gearbox with level scale.
- Check the hydraulic pressure pump for proper pressure build up if required adjust the knob for required pressure.
- Check the oil level in the speed variator through view glass if required refill the prescribed lubrication oil up to mark.
- Check all inter locks are working properly if require tighten all screw fastenings.
- Check the chilled water flow through the rollers for proper cooling.
- Check the augur motor gearbox oil level with level scale if require refill the oil up to the mark.
- Monthly Maintenance
- Check the oil level in the Hydraulic pump through the view glass if required top up the lubricant up to the mark.
- Check the timer belt for proper working condition.
- Check the speed adjustment potential meter of speed variator for proper working.
- Check the Speedo meters and Ammeters are working properly if require Clean the contactors with CTC and tight the screw fastenings.
- Check that the on/off and reverse/forward switches are in working condition.
- Check that the inductive proximity sensors are in working condition.
- Check for water leakages from the rollers if require replace the oil seals of the water circulating ring.
- Check the PU tubes and PU connectors for leakages.
- Check the hydraulic hose pipe connectors for leakages if found tight with Teflon tape.
- Yearly Maintenance
- Check the main motor for abnormality if require replace the motor bearings with new one.
- Check the augur motor for abnormality if require replace the motor bearings with new one.
- Drain the oil of speed variator unit and refill the fresh prescribed lubrication oil up to the mark in the view glass.
- Drain the hydraulic pump oil and refill the fresh oil up to the mark.
- Check the Knurled roller bearings condition if required replace with new one.
- Check the Hydraulic hosepipes for leakages if required replace the hosepipes with new hosepipes.
- CTC: CARBON TETRA CHLORIDE
- Annexure – 1 Weekly preventive maintenance checklist
- Annexure – 2 Monthly preventive maintenance checklist
- Annexure – 3 Yearly preventive maintenance checklist
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As we know that stirrer is used for Mixing of solid ingredients in the solvent.
To verify and document the installation, operation and performance of Overhead Stirrer with Tank-XYZ L and to ascertain that the machine operates as designed and performs to meet the predefined acceptance criteria.
The scope of this qualification report is limited to Overhead Stirrer with Tank-420 L having ID no. XYZ .
3.0 RESPONSIBILITIES :
Maintenance Officer/Executive: To prepare qualification report and co-ordinate the entire qualification activity.
Quality Assurance Officer/Executive: To witness the qualification study and ascertain that the study is conducted as per the protocol.
Production Officer/Executive: To execute qualification study in co-ordination with other departments.
Head Maintenance: To review the qualification documents.
Head Quality Assurance: To approve the qualification report.
4.0 EQUIPMENT DESCRIPTION :
Equipment comprises shell, bottom dish, lid, flange, ball valve, agitator, flame proof motor, variable frequency drive (VFD) and emergency OFF button. All contact parts is SS 316 L and mirror finished.
5.0 ACCEPTANCE CRITERIA:
Qualification of the equipment should meet the acceptance criteria outlined in the following steps.
- Calibration status report of Multimeter device
|Sr.No.||Device||Acceptance criteria||Observation||Checked by date/sign|
|1||Multimeter||It shall be calibrated for its performance.|
- Installation verification report
|Sr.No.||Check points||Acceptance criteria||Observation||Checked by date/sign|
|1||Check the condition of the equipment on receipt visually.||Visually there should not be any abnormality.|
|2||Check the levelling of the equipment using level indicator.||Air bubble shall be at centre position of level indicator.|
|3||Check the major components and their electrical cables for housing and anchoring.||Major components and their electrical cables shall be securely housed and anchored.|
- Technical and sub components specification verification report
|Sr.No.||Check points||Acceptance criteria||Observation||Checked by date/sign|
|1||Tank diameter||2 feet or more|
|3||Discharge||1” BSP outlet with ball valve|
|4||Speed control||960 rpm propeller agitator with speed control VFD.|
|5||Discharge height||2 feet mm from ground level|
|6||Agitator||1 HP, Speed variable up to 960 rpm, shaft diameter 20 mm, Top tank mounting.|
|7||Castor wheels||Shall be provided for ease in movement of the machine.|
|8||Motor||1 HP, Make: Hindustan|
|9||Emergency push button||Make: Tecknic|
- Utility verification report
|Sr.No.||Utility||Acceptance criteria||Observation||Checked by date/sign|
|1||Electricity||Three phase, 410 V ± 5% and 50 Hz ± 5%|
- Safety features verification report
|Sr.No.||Safety features||Acceptance criteria||Observation||Checked by date/sign|
|1||Earthing||Earthing shall be provided to equipment.|
|2||AC motor||AC motor shall be covered with SS guards.|
|3||Emergency stop||Emergency stop button shall be provided on operating panel.|
- Material of construction (MOC) and test certificate verification checklist
|Sr.No.||Components||Acceptance criteria||Observation||Checked by date/sign|
|1||MOC of contact parts i.e. shell, lid, dish, flange and ball valve||SS 316 L and mirror finished.|
|2||Motor||It shall be tested for its performance.|
|3||AC drive||It shall be tested for its performance.|
- Operational verification report
|Sr.No.||Operation||Acceptance criteria||Observation||Checked by date/sign|
|1||Turn the main ON/OFF switch at ON position.||Red indication lamp should glow.|
|2||Press the start button.||Green indication lamp should glow and equipment should start.|
|3||Rotate speed spot in clockwise direction step by step up to last point.||Agitator speed shall be raised gradually.Rotation of agitator shall be smooth and noise and vibration free.|
|4||Press the emergency stop button.||Rotation of agitator shall be stopped immediately.|
|Sr.No.||Operation||Acceptance criteria||Observation||Checked by date/sign|
|5||Release the emergency stop button and re-start the equipment.||Agitator of equipment should re-start.|
|6||Press the stop button.||Green indication lamp should turn OFF and equipment should stop.|
- Performance verification report Performance of equipment is verified by simulating the normal operation for preparation of colour coating solution. After completion of preparation, physically checked the colour coating solution for its appearance. Observation of procedure followed for preparation of colour coating solution:
Colour coating solution quantity:
|Sr.No.||Procedure||Observation||Checked by date/sign|
|1||Stirring: Add the Isopropyl Alcohol (IPA), Hydroxy Propyl Methyl Cellulose (HPMC) and Methylene Chloride into 420 L tank, stir for 15 minutes.|
|Sr.No.||Procedure||Observation||Checked by date/sign|
|2||Milling: Add Colour, Isopropyl Alcohol (IPA) and Titanium Dioxide into container and stir manually for about 10 minutes and pass through Colloidal Mill for 15 minutes milling.|
|3||Stirring: Add the step No. 2 solution and polyethylene glycol into step No. 1 with continuous stirring for 30 minutes.|
|4||Filtration: Filter the coating solution through 100 # sieve.|
- Acceptance criteria:
- Colour coating solution should be clear and free from fines of colour material.
- Mechanical operation should be satisfactory.
- Observation of colour coating solution:
6.0 DEVIATION REPORT:
|Sr. No.||Deviation (s)||Justification for acceptance criteria||Impact on installation, operation and performance|
7.0 CHANGE CONTROL:
Mention change control number if any
8.0 LIST OF ANNEXURE :
Mention annexure number if any
9.0 SUMMARY OF QUALIFICATION AND CONCLUSION :
Mention in details i.e what parameters you have checked and what is your observation
10.0 CERTIFICATION OF QUALIFICATION :
Qualification is satisfactory Yes/No
Hence Overhead Stirrer with Tank-150 L is suitable for routine use. Yes/No
Head – QA
(For alert limit)
- If the colony forming units exceed the alert limit
a) Increase the frequency of cleaning from once to twice a shift.
b) Ensure that the disinfectants are used as per schedule mentioned in respective SOP
and Cleaning of the processing area is carried out as per respective SOP .
(For action limit)
- If the colony forming units exceed the action limit, investigate / check the following whether
- Entry / Gowning procedure is followed.
- Cleaning is done as per SOP in processing and filling area.
- Disinfectant schedule is followed as per respective SOP
- Prolonged Maintenance job performed if any.
- Personnel traffic in the area is increased.
- Major Power shut down has occurred.
- Positive pressure in the area is disturbed.
- Operator with history of adverse fingerprint reports worked in the area.
- Time of plate exposure.
- Any other incidence, which can increase the bioburden of the area, took place.
- Inform to QC dept. through QA dept. in writing the outcome of above investigation with Products / Batches manufactured and filled during the period.
- During the investigation period, increase the frequency of cleaning to twice a shift.
- Request QC dept. to identify the organism and suggest suitable disinfectant for the organism identified.
- Proceed as per the suggestions given by QC dept.