All Department SOPs, Change Control, Deviation, CAPA, Stability, Nitrosamine Impurity & Elemental impurity Risk Assessment, Quality Risk Assessment Case study, Process Validation Protocol & Reports


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Herbal Medicinal Products Manufacturing Minimum requirements


Principle :

Because of their often complex and variable nature, control of starting materials, storage and processing assume particular importance in the manufacture of herbal medicinal products.
The “starting material” in the manufacture of an herbal medicinal product can be a medicinal plant, an herbal substance or an herbal preparation. The herbal substance should be of suitable quality and supporting data should be provided to the manufacturer of the herbal preparation/herbal medicinal product. Ensuring consistent quality of the herbal substance may require more detailed information on its agricultural production. The selection of seeds, cultivation and harvesting conditions represent important aspects of the quality of the herbal substance and can influence the consistency of the finished product. Recommendations on an appropriate quality assurance system for good agricultural and collection practice are provided in national or international guidance documents on Good Agricultural and Collection Practice for starting materials of herbal origin.
This Annex applies to all herbal starting materials: medicinal plants, herbal substances or herbal preparations.

Table illustrating the application of Good Practices to the manufacture of herbal medicinal products

ActivityGood Agricultural and Collection Practice (GACP) #Part II of the GMP Guide †Part I of the GMP Guide †
Cultivation, collection and harvesting of plants, algae, fungi and lichens, and collection of exudates
Cutting, and drying of plants, algae, fungi, lichens and exudates *
Expression from plants and distillation**
Comminution, processing of exudates, extraction from plants, fractionation, purification, concentration or fermentation of herbal substances
Further processing into a dosage form including packaging as a medicinal product

Explanatory Notes
†..The GMP classification of the herbal material is dependent upon the use made of it by the manufacturing authorisation holder. The material may be classified as an active substance, an intermediate or a finished product. It is the responsibility of the manufacturer of the medicinal product to ensure that the appropriate GMP classification is applied.

*Manufacturers should ensure that these steps are carried out in accordance with the marketing authorisation / registration. For those initial steps that take place in the field, as justified in the marketing authorisation / registration, the national or international standards of Good Agricultural and Collection Practice for starting materials of herbal origin (GACP)# are applicable. GMP is applicable to further cutting and drying steps.


** Regarding the expression from plants and distillation, if it is necessary for these activities to be an integral part of harvesting to maintain the quality of the product within the approved specifications, it is acceptable that they are performed in the field, provided that the cultivation is in compliance with national or international standards of GACP#. These circumstances should be regarded as exceptional and justified in the relevant marketing authorisation / registration documentation. For activities carried out in the field, appropriate documentation, control, and validation according to the GMP principles should be assured. Regulatory authorities may carry out GMP inspections of these activities in order to assess compliance.

Premises :

Storage areas :

Herbal substances should be stored in separate areas. The storage area should be equipped in such a way as to give protection against the entry of insects or other animals, especially rodents. Effective measures should be taken to prevent the spread of any such animals and micro-organisms brought in with the crude substance, to prevent fermentation or mould growth and to prevent cross-contamination. Different enclosed areas should be used to quarantine incoming herbal substances and for the approved herbal substances.

The storage area should be well aerated and the containers should be located in such a way as to allow free circulation of air.

Special attention should be paid to the cleanliness and good maintenance of the storage areas particularly when dust is generated.

Storage of herbal substances and herbal preparations may require special conditions of humidity, temperature or light protection; these conditions should be provided and monitored.

Production area :

Specific provisions should be made during sampling, weighing, mixing and processing operations of herbal substances and herbal preparations whenever dust is generated, to facilitate cleaning and to avoid cross-contamination, as for example, dust extraction, dedicated premises, etc.

Equipment :

The equipment, filtering materials etc. used in the manufacturing process must be compatible with the extraction solvent, in order to prevent any release or undesirable absorption of substance that could affect the product.

Documentation :

Specifications for starting materials :

Herbal medicinal product manufacturers must ensure that they use only herbal starting materials manufactured in accordance with GMP and the Marketing Authorisation dossier. Comprehensive documentation on audits of the herbal starting material suppliers carried out by, or on behalf of the herbal medicinal product manufacturer should be made available. Audit trails for the active substance are fundamental to the quality of the starting material. The manufacturer should verify, where appropriate, whether the suppliers of the herbal substance / preparation are in compliance with Good Agricultural and Collection Practice and – if not – apply appropriate controls in line with Quality Risk Management (QRM).

To fulfil the specification requirements described in the basic requirements of the Guide (Chapter 4), documentation for herbal substances / preparations should include:

  • the binomial scientific name of plant (genus, species, subspecies / variety and author (e.g. Linnaeus); other relevant information such as the cultivar name and the chemotype should also be provided, as appropriate;
  • details of the source of the plant (country or region of origin and where applicable, cultivation, time of harvesting, collection procedures, possible pesticides used, possible radioactive contamination, etc.);
  • which part(s) of the plant is/are used;
  • when a dried plant is used, the drying system should be specified;
  • a description of the herbal substance and its macro and microscopic examination;
  • suitable identification tests including, where appropriate, identification tests for constituents with known therapeutic activity, or markers. Specific distinctive tests are required where an herbal substance is liable to be adulterated / substituted. A reference authentic specimen should be available for identification purposes;
  • the water content for herbal substances, determined in accordance with the relevant Pharmacopoeia;
  • assay of constituents of known therapeutic activity or, where appropriate, of markers; the methods suitable to determine possible pesticide contamination and limits accepted in accordance with relevant Pharmacopoeia methods or, in absence of thereof, with an appropriate validated method, unless otherwise justified;
  • tests to determine fungal and/or microbial contamination, including aflatoxins, other mycotoxins, pest-infestations and limits accepted, as appropriate;
  • tests for toxic metals and for likely contaminants and adulterants, as appropriate;
  • tests for foreign materials, as appropriate;
  • any other additional test according to the relevant Pharmacopoeia general monograph on herbal substances or to the specific monograph of the herbal substance, as appropriate.

Any treatment used to reduce fungal/microbial contamination or other infestation should be documented. Specifications and procedures should be available and should include details of process, tests and limits for residues.

Processing instructions :

The processing instructions should describe the different operations carried out upon the herbal substance such as cleaning, drying, crushing and sifting, and include drying time and temperatures, and methods used to control cut size or particle size

In particular, there should be written instructions and records, which ensure that each container of herbal substance is carefully examined to detect any adulteration/substitution or presence of foreign matter, such as metal or glass pieces, animal parts or excrement, stones, sand, etc., or rot and signs of decay.

The processing instructions should also describe security sieving or other methods of removing foreign materials and appropriate procedures for cleaning/selection of plant material before the storage of the approved herbal substance or before the start of manufacturing.

For the production of an herbal preparation, instructions should include details of solvent, time and temperatures of extraction, details of any concentration stages and methods used.

Quality Control:

Sampling :

Due to the fact that medicinal plant/herbal substances are heterogeneous in nature, their sampling should be carried out with special care by personnel with particular expertise. Each batch should be identified by its own documentation.

A reference sample of the plant material is necessary, especially in those cases where the herbal substance is not described in the relevant Pharmacopoeia. Samples of unmilled plant material are required if powders are used.

Quality Control personnel should have particular expertise and experience in herbal substances, herbal preparations and/or herbal medicinal products in order to be able to carry out identification tests and recognise adulteration, the presence of fungal growth, infestations, non-uniformity within a delivery of crude material, etc.

The identity and quality of herbal substances, herbal preparations and herbal medicinal products should be determined in accordance with the relevant current national or international guidance on quality and specifications of herbal medicinal products and traditional herbal medicinal products and, where relevant, to specific pharmacopoeial monographs.

Reference : PIC/S Good Manufacturing Practices for Medicinal Products https://picscheme.org/docview/4102

Quality Risk Management Potential uses in Pharmaceuticals


Introduction :

Risk managementprinciples are effectively utilized in many areas of business and government including finance, insurance, occupational safety, public health, pharmacovigilance, and by agencies regulating these industries.

Quality risk management is used in the pharmaceutical industries and it is becoming evident that quality risk management is a valuable component of an effective quality system.

Advantages of Quality risk Management:

An effective quality risk management approach can further ensure the high quality of the drug (medicinal) product to the patient by providing a proactive means to identify and control potential quality issues during development and manufacturing.

The use of quality risk management can improve the decision making if a quality problem arises.

Effective quality risk management can facilitate better and more informed decisions, can provide regulators with greater assurance of a company’s ability to deal with potential risks and can beneficially affect the extent and level of direct regulatory oversight.

This Appendix is intended to identify potential uses of quality risk management principles and tools by industry and regulators. However, the selection of particular risk management tools is completely dependent upon specific facts and circumstances. These examples are provided for illustrative purposes and only suggest potential uses of quality risk management (but not limited to).

1. Quality Risk Management as Part of Integrated Quality Management
Documentation
To review current interpretations and application of regulatory expectations
To determine the desirability of and/or develop the content for SOPs, guidelines, etc.
Training and education
To determine the appropriateness of initial and/or ongoing training sessions based on education, experience and working habits of staff, as well as on a periodic assessment of previous training (e.g., its effectiveness)
To identify the training, experience, qualifications and physical abilities that allow personnel to perform an operation reliably and with no adverse impact on the quality of the product
Quality defects
To provide the basis for identifying, evaluating, and communicating the potential quality impact of a suspected quality defect, complaint, trend, deviation, investigation, out of specification result, etc.
To facilitate risk communications and determine appropriate action to address significant product defects, in conjunction with regulatory authorities (e.g., recall)
Auditing/Inspection
To define the frequency and scope of audits, both internal and external, taking into account factors such as:
• Existing legal requirements
• Overall compliance status and history of the company or facility
• Robustness of a company’s quality risk management activities
• Complexity of the site
• Complexity of the manufacturing process
• Complexity of the product and its therapeutic significance
• Number and significance of quality defects (e.g. recall)
• Results of previous audits/inspections

  • Major changes of building, equipment, processes, key personnel
  • Experience with manufacturing of a product (e.g. frequency, volume, number of batches)
  • Test results of official control laboratories

Periodic review
To select, evaluate and interpret trend results of data within the product quality review
To interpret monitoring data (e.g., to support an assessment of the appropriateness of re validation or changes in sampling)
Change management / change control
To manage changes based on knowledge and information accumulated in pharmaceutical development and during manufacturing
To evaluate the impact of the changes on the availability of the final product
To evaluate the impact on product quality of changes to the facility, equipment, material, manufacturing process or technical transfers
To determine appropriate actions preceding the implementation of a change, e.g., additional testing, (re)qualification, (re)validation or communication with regulators
Continual improvement
To facilitate continual improvement in processes throughout the product lifecycle

2. Quality Risk Management as Part of Regulatory Operations

Inspection and assessment activities
To assist with resource allocation including, for example, inspection planning and frequency, and inspection and assessment intensity.
To evaluate the significance of, for example, quality defects, potential recalls and inspectional findings
To determine the appropriateness and type of post-inspection regulatory follow-up
To evaluate information submitted by industry including pharmaceutical development information
To evaluate impact of proposed variations or changes

To identify risks which should be communicated between inspectors and assessors to facilitate better understanding of how risks can be or are controlled (e.g. parametric release, Process Analytical Technology (PAT)).

3. Quality Risk Management as Part of Development

To design a quality product and its manufacturing process to consistently deliver the intended performance of the product (see ICH Q8)
To enhance knowledge of product performance over a wide range of material attributes (e.g. particle size distribution, moisture content, flow properties), processing options and process parameters
To assess the critical attributes of raw materials, solvents, Active Pharmaceutical Ingredient (API) starting materials, APIs, excipients, or packaging materials
To establish appropriate specifications, identify critical process parameters and establish manufacturing controls (e.g., using information from pharmaceutical development studies regarding the clinical significance of quality attributes and the ability to control them during processing)
To decrease variability of quality attributes:
• reduce product and material defects
• reduce manufacturing defects
To assess the need for additional studies (e.g., bioequivalence, stability) relating to scale up and technology transfer
To make use of the “design space” concept (see ICH Q8).

4. Quality Risk Management for Facilities, Equipment and Utilities

Design of facility / equipment
To determine appropriate zones when designing buildings and facilities, e.g.,
• flow of material and personnel
• minimize contamination
• pest control measures
• prevention of mix-ups
• open versus closed equipment
• clean rooms versus isolator technologies
• dedicated or segregated facilities / equipment
To determine appropriate product contact materials for equipment and containers (e.g., selection of stainless steel grade, gaskets, lubricants)
To determine appropriate utilities (e.g., steam, gases, power source, compressed air, heating, ventilation and air conditioning (HVAC), water).

To determine appropriate preventive maintenance for associated equipment (e.g., inventory of necessary spare parts).

Hygiene aspects in facilities
To protect the product from environmental hazards, including chemical, microbiological, and physical hazards (e.g., determining appropriate clothing and gowning, hygiene concerns)
To protect the environment (e.g., personnel, potential for cross-contamination) from hazards related to the product being manufactured
Qualification of facility/equipment/utilities
To determine the scope and extent of qualification of facilities, buildings, and production equipment and/or laboratory instruments (including proper calibration methods)
Cleaning of equipment and environmental control
To differentiate efforts and decisions based on the intended use (e.g. multi-versus single-purpose, batch versus continuous production)
To determine acceptable (specified) cleaning validation limits
Calibration/preventive maintenance
To set appropriate calibration and maintenance schedules
Computer systems and computer controlled equipment
To select the design of computer hardware and software (e.g., modular, structured, fault tolerance)
To determine the extent of validation, e.g.:
• identification of critical performance parameters
• selection of the requirements and design
• code review
• the extent of testing and test methods
• reliability of electronic records and signatures

5. Quality Risk Management as Part of Materials Management

Assessment and evaluation of suppliers and contract manufacturers
To provide a comprehensive evaluation of suppliers and contract manufacturers (e.g., auditing, supplier quality agreements)

Starting material
To assess differences and possible quality risks associated with variability in starting materials (e.g., age, route of synthesis).
Use of materials
To determine whether it is appropriate to use material under quarantine (e.g., for further internal processing)
To determine appropriateness of reprocessing, reworking, use of returned goods
Storage, logistics and distribution conditions
To assess the adequacy of arrangements to ensure maintenance of appropriate storage and transport conditions (e.g., temperature, humidity, container design)
To determine the effect on product quality of discrepancies in storage or transport conditions (e.g. cold chain management) in conjunction with other ICH guidelines
To maintain infrastructure (e.g. capacity to ensure proper shipping conditions, interim storage, handling of hazardous materials and controlled substances, customs clearance)
To provide information for ensuring the availability of pharmaceuticals (e.g. ranking risks to the supply chain).

6. Quality Risk Management as Part of Production

Validation
To identify the scope and extent of verification, qualification and validation activities (e.g., analytical methods, processes, equipment and cleaning methods
To determine the extent for follow-up activities (e.g., sampling, monitoring and re-validation)
To distinguish between critical and non-critical process steps to facilitate design of a validation study
In-process sampling & testing
To evaluate the frequency and extent of in-process control testing (e.g., to justify reduced testing under conditions of proven control)
To evaluate and justify the use of process analytical technologies (PAT) in conjunction with parametric and real time release
Production planning
To determine appropriate production planning (e.g. dedicated, campaign and concurrent production process sequences).

7. Quality Risk Management as Part of Laboratory Control and Stability Studies
Out of specification results
To identify potential root causes and corrective actions during the investigation of out of specification results
Retest period / expiration date
To evaluate adequacy of storage and testing of intermediates, excipients and starting materials.

8. Quality Risk Management as Part of Packaging and Labelling

Design of packages
To design the secondary package for the protection of primary packaged product (e.g., to ensure product authenticity, label legibility)
Selection of container closure system
To determine the critical parameters of the container closure system
Label controls
To design label control procedures based on the potential for mix-ups involving different product labels, including different versions of the same label

Induction Cap Sealing Machine Performance Qualification Protocol


Equipment Name :Induction Cap Sealing Machine
Equipment Model No.:Sigma – II
Equipment Sr. No.:213/11/-12
Equipment ID No.:XYZ
Equipment Area :XYZ
Equipment Manufacturer Name :Electronic Devices, Mumbai
Equipment Application :To seal aluminium foil (sealing wad) retained in head space of cap with lip of HDPE bottles (containing product) online by induction sealing method.
Protocol Effective Date : 

PROTOCOL APPROVAL:

 Prepared byChecked byChecked byChecked byApproved by
Signature       
Date     
Name     
DepartmentProductionHead-ProductionQuality AssuranceEngineeringHead – Quality Assurance
  1. OBJECTIVE:
    1. To give the methodology and procedures for performing performance qualification of the newly procured Induction Cap Sealing Machine on the bottling packaging line having ID XYZ.
2.0        SCOPE:
  • The scope of this exercise is limited to Induction Cap Sealing Machine having ID No. XYZ.
3.0        RESPONSIBILITIES:
  • Quality Assurance Officer/Executive: To prepare qualification protocol 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 review and approve the qualification protocol and report.
  • 4.0 EQUIPMENT DESCRIPTION:
    • Refer installation qualification protocol No.: XYZ.
  • 5.0 PROCEDURE:

Qualification of the equipment should meet the acceptance criteria outlined in the following steps.

  • 5.1 Performance Verification of Equipment:
  • 5.1.1 Performance of the equipment shall be verified by simulating the normal operation i.e. sealing of aluminium foil (sealing wad) retained in head space of cap with lip of HDPE bottles (containing product) online. While doing this exercise consideration shall give to the operating range of the equipment’s i.e. size of bottle (40 cc and 1300 cc bottles), size of cap (33 mm and 53 mm caps) and speed of conveyor.
  • 5.1.2 The data generated during PQ study shall be recorded in the qualification report.
  • 5.1.3 Sealing of 33 mm Caps with 40 cc HDPE Bottles at different speed
  • 5.1.3.1 Before starting of equipment, set it as per 33 mm cap and 40 cc bottle.
  • 5.1.3.2 The ‘gap between induction sealing head and bottle cap’ and ‘induction heating power in %’ shall be adjusted as per conveyer speed and cap/bottle size until the bottle is sealed properly. Same shall be recorded in the report.
  • 5.1.3.3 Once the equipment set, start to supply HDPE bottles containing product on infeed conveyor with variable conveyor speed one by one.
  • 5.1.3.4 Equipment shall be run at each speed.
  • 5.1.3.5 Randomly collect the few sealed bottles from out feed conveyor and Check physically for improper sealing and burned sealing wad and inside surface of cap. Check for any leakage at sealed portion by Leak test as per SOP No.: XYZ.
  • 5.1.3.6 While running the equipment at each speed, place foil (sealing wad) missing cap bottle on infeed conveyor as challenge to foil missing cap bottle detect sensor and at same time check whether that inferior bottle is rejected by reject cylinder automatically and alarm message is flashed on LCD screen.
  • 5.1.4 Sealing of 53 mm Caps with 1300 cc HDPE Bottles at different speed
  • 5.1.4.1 Steps 5.1.3.1 to 5.1.3.6 shall be followed for study with 53 mm Cap and 1300 cc HDPE Bottle.

5.1.5 Critical parameters and acceptance criteria:

Sr. No.Critical parameterAcceptance criteria
1.0Check for improper sealing and burned sealing wad and inside surface of cap.There shall be no single bottle found with improper sealing and burned sealing wad and inside surface of cap.
2.0Leak testLeak test shall be negative i.e. tablets, silica gel sachet and cotton shall not be moistened.
3.0Foil (sealing wad) missing cap bottle detect sensor challenge testMessage ‘No Foil’ shall appear on LCD screen.Red colour lamp shall glow on.Buzzer shall off.Reject cylinder shall reject foil (sealing wad) missing cap bottle online.
4.0Record the set gap between induction sealing head and bottle cap at each bottle size and speed study.For data collection. 
5.0Record the actual heating power in % at each bottle size and speed study.For data collection.
  • 6.0 DEVIATION REPORT:
    • Any deviation occurred during the qualification study shall be documented. The impact on installation qualification of equipment by the deviation shall be evaluated and documented.
  •  7.0 CHANGE CONTROL:
    • Any change occurred during the qualification study shall be documented. The impact on installation qualification of equipment by the change shall be evaluated and documented.
  • 8.0 SUMMARY AND CONCLUSION OF PERFORMANCE QUALIFICATION:
    • Based on the data collected during qualification, appropriate summary and conclusion shall be made on the performance qualification.
  • 9.0 REPORT APPROVAL:
    • All the data collected during qualification study shall be recorded in the qualification report along with adequate raw data. The report shall be finally approved by Head-QA.

10.0 REFERENCES:

Nil

Induction Cap Sealing Machine Performance Qualification Report


  Equipment Name :Induction Cap Sealing Machine
Equipment Model No.:Sigma – II
Equipment Sr. No.:213/11/-12
Equipment ID No.:XYZ
Equipment Area :XYZ
Equipment Manufacturer Name :Electronic Devices, Mumbai
Equipment Application :To seal aluminium foil (sealing wad) retained in head space of cap with lip of HDPE bottles (containing product) online by induction sealing method.
Report Date : 

REPORT APPROVAL:

 Prepared byChecked byChecked byChecked byApproved by
Signature       
Date     
Name     
DepartmentProductionHead-ProductionQuality AssuranceHead -EngineeringHead – Quality Assurance
  1. OBJECTIVE:
    1. Objective is to record the findings of performance qualification (PQ) of Induction Cap Sealing Machine.
2.0        SCOPE:
  • The scope of this exercise is limited to Induction Cap Sealing Machine having ID No. XYZ.
3.0      RESPONSIBILITIES:
  • Quality Assurance 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 review and approve the qualification protocol and report.
  • 4.0 EQUIPMENT DESCRIPTION:
    • Refer installation qualification protocol No.: XYZ.
  • 5.0 PROCEDURE:

Qualification of the equipment should meet the acceptance criteria outlined in the following steps.

  • 5.1 Performance Verification Report:
  • 5.1.1 Performance of the equipment shall be verified by simulating the normal operation i.e. sealing of aluminium foil (sealing wad) retained in head space of cap with lip of HDPE bottles (containing product) online. While doing this exercise consideration shall give to the operating range of the equipments i.e. size of bottle (40 cc and 1300 cc bottles), size of cap (33 mm and 53 mm caps) and speed of conveyor.
  • 5.1.2 The generated data during performance of equipment are recorded in a following table.
  • 5.1.3 Acceptance Criteria:
  • 5.1.3.1 There shall be no single bottle found with improper sealing and burned sealing wad and inside surface of cap.
  • 5.1.3.2 Leak test shall be negative i.e. tablets, silica gel canister and cotton shall not be moistened.

5.1.1 Observations of sealing of 33mm Caps on 40cc HDPE bottles at different speed

Product Name 
Bottle Size 
Cap type 
Cap size 
Distance between coil and Cap surface 
Sr. NoSpeed of ConveyorSet Power Level Range in %Actual Power Level in %Observations of Sealing QualityObservations of Burned WadObservations of Leak testChecked by sign/date
1.020 Hertz92-98%     
Sr. NoSpeed of ConveyorSet Power Level Range in %Actual Power Level in %Observations of Sealing QualityObservations of Burned WadObservations of Leak testChecked by sign/date
2.030 Hertz92-98%     
Sr. NoSpeed of ConveyorSet Power Level Range in %Actual Power Level in %Observations Sealing QualityObservations Burned WadObservations of Leak testChecked by sign/date
3.040 Hertz92-98%     

5.1.2 Challenge test report

Sr. No.Simulation OperationAcceptance CriteriaObservationsChecked by Sign/Date
1.0Foil (sealing wad) missing cap bottle detect sensor challenge testMessage ‘No Foil’ shall appear on LCD screen.Red colour lamp shall glow on.Buzzer shall off.Reject cylinder shall reject foil (sealing wad) missing cap bottle online.  

Remarks / Comments:

5.1.3 Observations of sealing of 53mm Caps on 1300cc HDPE bottles at different speed

Product Name
Bottle Size
Cap type
Cap size
Distance between coil and Cap surface
Sr. NoSpeed of ConveyorSet Power Level Range in %Actual Power Level in %Observations of Sealing QualityObservations of Burned WadObservations of Leak testChecked by sign/date
1.020 Hertz60-70%     
Sr. NoSpeed of ConveyorSet Power Level Range in %Actual Power Level in %Observations of Sealing QualityObservations of Burned WadObservations of Leak testChecked by sign/date
2.030 Hertz70-80%     
Sr. NoSpeed of ConveyorSet Power Level Range in %Actual Power Level in %Observations of Sealing QualityObservations of Burned WadObservations of Leak testChecked by sign/date
3.040 Hertz92-98%     

5.1.4 Challenge test report

Sr. No.Simulation OperationAcceptance CriteriaObservationsChecked by Sign/Date
1.0Foil (sealing wad) missing cap bottle detect sensor challenge testMessage ‘No Foil’ shall appear on LCD screen.Red colour lamp shall glow on.Buzzer shall off.Reject cylinder shall reject foil (sealing wad) missing cap bottle online.  

Remarks / Comments:

5.0 DEVIATION REPORT:

Sr. No.Deviation (s)Justification for acceptance criteriaImpact on installation, operation and performance
            
            
            
  • 6.0 CHANGE CONTROL:
  • 7.0 LIST OF ANNEXURE:

8.0 SUMMARY AND CONCLUSION OF PERFORMANCE  QUALIFICATION:

9.0 CERTIFICATION OF PERFORMANCE QUALIFICATION:

Performance Qualification is satisfactory.                                     Yes/No

Hence equipment can be used for routine use.                            Yes/No

                                                                                               Head- Q.A.

For PQ Protocol can Refer https://pharmaceuticalupdates.com/2021/07/07/induction-cap-sealing-machine-performance-qualification-protocol/