conducted for food stuff - safetyculture · procedure for oos results, how is this ... (apis)...

General GMP Checklistconducted for

Food Stuff

LocationGuildfordGU4England(51.20771158797609, -0.5336910077536141)

Conducted on18 Jul 2018 02:49 PM

Prepared byGrace Stuff

Completed on18 Jul 2018 03:43 PM

Score160/164.0 - 97.56%

Failed ResponsesThis section lists responses that were set as "failed responses" in the template used for thisaudit

Question Response Details

Facility grounds are well maintainedincluding roads, parking lots, grass anddrain areas.

✖Patchy grass.

Appendix 1

Are there enough resources (qualifiedpeople, testing equipment, etc) toadequately perform this function?

✖Need to hire a replacement for theemployee who resigned.

Access to the label storage areas shouldbe limited to authorized personnel. ✖

Label storage area needs to be moresecure. Perhaps keycard access can beimplemented for this room.

An up-to-date organization chart withnames/key personnel available. ✖

There was an employee who resignedtwo weeks ago and org chart is yet to beupdated.

Food Stuff / 18 Jul 2018 / Grace Stuff - 2 -

1- Buildings and Facilities - 29/30 96.67%


1.1 Design and Construction Score (8/9) 88.89%

Facility grounds are well maintainedincluding roads, parking lots, grass anddrain areas.

✖Patchy grass.

Appendix 1

REFERENCE: Manufacturing facilities inside and outside are clean[This is an example of how you can use iAuditor to include best practice reference images in yourtemplates to assist with inspections]

Score (29/30) 96.67%Food Stuff / 18 Jul 2018 / Grace Stuff

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There is adequate space provided fororderly placement of equipment andmaterials to prevent mix-ups andcontamination.

✔

Appropriate environmental controls existand are maintained (controlledtemperature, air filtration, humidity,lighting, etc...).

✔

All food contact surfaces are made ofmaterials appropriate to the application(i.e. stainless steel vs. aluminum).

✔

All water systems are adequatelyprotected against back flow. ✔

There are adequate hand-washingfacilities for rest rooms, break areas andmanufacturing areas.

✔

Floors, walls, ceilings, doors and windowsare completely sealed to prevent entry ofpests.

✔

Loading dock doors are flush to the floorwhen closed. ✔


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There is separation of defined areas andadequate controls to preventcontamination.

✔

1.2 Construction and Maintenance Score (5/5) 100.00%

Non-toxic and corrosion-resistantmaterials such as stainless steel arebeing used around the process.

✔

Seams are well bonded and smooth. ✔

Lubricants and chemicals used foroperation of equipment are approved forfood grade applications.

✔

A preventative maintenance programdeveloped and implemented for majorequipment.

✔

Weighing, measuring, monitoring, andtesting equipment critical for ensuringquality should be calibrated according towritten procedures, establishedschedules and using certified or traceablestandards.

✔

1.3 Pest control program Score (7/7) 100.00%

A documented pest control program is inplace. ✔ Scheduled pest control is enforced.

Building exterior is protected fromrodent and pest entry. ✔

Map with locations of all traps identified ✔

The pest control program includesfrequent inspections. ✔

The supplier maintains and enforceswritten procedures for the application ofpesticides.

✔

All chemicals used in pest control areaccurately labeled and stored securely ✔

The facility audits pest control operatorperformance. ✔


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1.4 Cleaning & Sanitation Score (9/9) 100.00%

There is a written and comprehensiveplant and equipment sanitation program. ✔

Facility and equipment maintenanceensures safe manufacture of wholesomefoods.

✔

There are written operating proceduresor work instructions. ✔

Brushes and other utensils used forcleaning food contact surfaces arecontrolled and clearly identified.

✔

Measures are in place to verify andmonitor the effectiveness of cleaningmethods.

✔

Cleaning and sanitization procedures arevalidated and well-documented as such. ✔

Cleaning and usage logs established formajor equipment to include: dates,products, lots#, person who used, personwho cleaned.

✔

Hoppers, tanks and similar foodreceptacles must be properly covered. ✔

A chemical control program manages theuse, storage, and handling of non-foodchemicals at the manufacturing facility.

✔


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2 - Materials Management - 12/12 100.00%


2.1 General Controls Score (5/5) 100.00%

There should be written proceduresdescribing the receipt, identification,quarantine, storage, handling, sampling,testing, and approval or rejections ofmaterials.

✔

There should be a system for control ofGMO/non-GMO allergens. ✔

Appropriate environmental controls existand are maintained (controlledtemperature, air filtration, humidity,lighting, etc...).

✔

Manufacturers of intermediates and/orAPIs should have a system for evaluatingthe suppliers of critical materials.

✔

Materials should be purchased against anagreed specification, from a supplier, orsuppliers, approved by the qualityunit(s)).

✔

2.2 Traceability Score (2/2) 100.00%

Lot trace system with distinctive lotnumber for all raw materials, in-processmaterials, finished goods, and packagingcomponents.

✔

Establish and document First-in/Firstout(FIFO) procedures for all materials andgoods.

✔

2.3 Storage Score (5/5) 100.00%

Materials should be handled and stored in a manner to prevent degradation, contamination, andcross-contamination.

Temperature and humidly ✔

Containers designed to protect againstadulteration. ✔

Store and/or control rejected materials insegregated facility so as to preventusage.

✔


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Warehouse area is clean and orderly -18"" perimeter is maintained. ✔

Materials should be re-evaluated, asappropriate, to determine their suitabilityfor use (e.g., after prolonged storage orexposure to heat or humidity).

✔


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3 - Quality Control Systems - 26/27 96.30%


3.1 Process Quality Control Plan (Packaging / Raw Materials) Score (6/6) 100.00%

A developed plan exists indicatinginspection frequency, # of samples &required tests

✔

Procedure for OOS results, how is thisinfo related to production, what is donewith product

✔

Systems are in place to ensure that youhave and are following the most currentcustomer specification.

✔

Does QC have a product standardreference system? ✔


✔

Are product retains kept (finished, rawmaterial, packaging) for a minimum ofshelf life + 1 year?

✔

3.2 Incoming Quality Control Score (5/5) 100.00%

A developed plan exists indicatinginspection frequency, # of samples &required tests.

✔

Procedure exists for handling out ofspecification (OOS) results. ✔

Does QC have updated productspecifications? ✔

Are customer product standardsavailable and used? ✔


✔

3.3 QC Micro Lab Score (6/7) 85.71%


✔


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Does Micro QC have updated productspecifications? ✔


✖Need to hire a replacement for theemployee who resigned.

Is there a documented, effective labcleaning & sanitization programincluding environmental monitoring?

✔

Does a documented calibration andmaintenance program exist? ✔

Does a validation program exist? ✔

3.4 QC Analytical Lab Score (9/9) 100.00%


✔


Does Analytical QC have updated productspecifications? ✔


✔

Does a documented calibration andmaintenance program exist? ✔

Does a validation program exist? ✔

Does a process exist for maintenance oflab standards? ✔

Does a process exist for the control &documentation of lab reagents? ✔

Establish, validate and document testmethods. ✔


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4 - Manufacturing - 17/17 100.00%


4.1 Batch Records Score (7/7) 100.00%

All documents related to the manufacture of intermediates or Active Pharmaceutical Ingredients(APIs) should be prepared, reviewed, approved and distributed according to a written SOP. Batchrecord:

Shall contain list of raw materials, names,characteristics, identification, lot #(s),weights.

✔

Shall include total and theoreticalweights/measures, min/max percentage.(Values outside acceptable rangesrequire investigation).

✔

Shall include detailed manufacturinginstructions & process control set pointsto assure purity, quality & consistentcomposition.

✔

Shall include documentation of eachsignificant step in the manufacturingprocess.

✔

Shall contain special notes ofinvestigation/deviation from theprescribed process.

✔

Shall be reviewed and approved byQuality Assurance (QA) for eachindividual batch run.

✔

Shall be retained for at least 1 year afterthe expiry date of the batch. ✔ Records are retained for more than a

year.

4.2 Contamination Score (2/2) 100.00%

Any material observed to have insectinfestation shall be quarantined andimmediately removed from premises.

✔

Effective measures shall be taken toprotect against metal and extraneousmaterials.

✔


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Identify and record usage of allcontainers, processing lines & majorequipment during production.

✔

Perform filling, assembling, packing, andother operations in such a way thatproducts are not adulterated.

✔

Methods for establishing & monitoringcritical process control points should bestated in writing.

✔

4.4 Manufacturing Process Controls Score (5/5) 100.00%

Developed plan indicating inspectionfrequency, # of samples, required tests ✔

Procedure exists for Out-of-Specificationresults. What is done with product? ✔

Are product standards routinely utilized? ✔

Is production set up to meet CustomerSpecifications and Requirements? ✔

Are there enough resources (qualifiedpeople, intermediate and final processchecks, etc) to assure the production of aquality product?

✔


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5 - Packaging and Identification Labeling - 11/12 91.67%



Establish and follow procedure for thereceipt, storage, handling, sampling,examination & reconciliation ofpackaging materials.

✔

Establish and follow procedure to ensurethat correct labels, labeling andpackaging materials are issued and use.

✔

5.2 Label Issuance and Control Score (5/6) 83.33%

Access to the label storage areas shouldbe limited to authorized personnel. ✖

Label storage area needs to be moresecure. Perhaps keycard access can beimplemented for this room.

Procedures should be established toreconcile the quantities of labels issued,used, and returned.

✔

Procedures should be established on howto investigate / evaluate anydiscrepancies found between number ofcontainers labeled and number of labelsissued.

✔

Procedures should be established for thedestruction of obsolete and out-datedlabels.

✔

Printed labels issued for a batch shouldbe carefully examined for proper identityand conformity to specifications in themaster production record.

✔

A printed label representative of thoseused should be included in the batchproduction record.

✔

5.3 Packaging and Labeling Operations Score (4/4) 100.00%

Provide adequate separation betweendifferent packaging / labeling operationsbeing carried out simultaneously in thesame area.

✔


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Identify packages and ingredients with alot number that permits determination ofhistory and control of batch.

✔

Examine packaged and labeled productsto ensure that they have the correct labeland lot #.

✔

Ensure that proper line clearanceprocedures are in place and utilizedduring changeovers.

✔


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6 - Quality Management Systems - 34/34 100.00%


6.1 Quality Goals Score (18/18) 100.00%

An organizational chart exists whichreflects the current reporting structure &responsibilities.

✔

Does the organization have anestablished and maintained qualitymanagement unit?

✔

There is a management representativewith defined authority and responsibilityfor meeting customer compliance.

✔

Qualified technical personnel areavailable for design, process, product,and service support.

✔One of the personnel is on leave but abackup has taken over.

A quality manual has been developedwhich details the quality system ofpolicies and procedures.

✔

Quality manual procedures identify • Whois responsible for action? • What has to bedone? • When are actions required?

✔

The responsibility for updating andrevising the quality manual and system iswell defined.

✔

Company quality objectives aredocumented, signed and dated. ✔

Quality objectives are communicated,understood, and maintained throughoutthe organization.

✔

Written procedures address the following types of planning:

• Establishment of requirements ✔

• Verification of requirements ✔

• Acceptance procedures ✔

• Quality information systems ✔

• Customer satisfaction ✔


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• Change control ✔

Ongoing quality improvements are a partof the plant manager’s objectives. ✔

Quality costs are used for evaluating andplanning. ✔

Documented evidence exists thatadvanced quality planning activities arereviewed with customers.

✔

6.2 Effectiveness of the Quality Management Systems Score (9/9) 100.00%

Lead times are measured and tracked ✔

The total cost of quality is tracked ✔

Cycle times measured and tracked ✔

Annual Quality improvement goals areset by top management ✔

Goals are regularly reviewed by topmanagement. ✔

There is a system in place to verify thatobjectives are met and quality policy isadhered to.

✔

Achievement of quality objectives is ahigh priority in overall performancereviews.

✔

The quality manual is regularly reviewed,revised, and communicated throughoutthe organization.

✔

There is a documented and objectiveprocess in place to measure and trackcustomer satisfaction.

✔

6.3 Internal Audits Score (7/7) 100.00%

There is a documented procedure forconducting internal quality audits. ✔

Internal audits are conductedsemi-annually or scheduled on the basisof status and importance of activity.

✔


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Audit includes work environment andgeneral housekeeping. ✔

Internal audit results are documentedand brought to attention ofmanagement.

✔

There is an established and documentedcomplaint investigation and responseprogram.

✔

Establish and document rework andreprocessing procedure ✔

Corrective actions are timely, recorded,and evaluated for effectiveness. ✔


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7 - Personnel and Training - 19/19 100.00%


7.1 Qualifications and Experience Score (3/3) 100.00%

An organizational chart exists whichreflects the most current reportingstructure.

✔

Job descriptions throughout theorganization include responsibilities forsupporting quality objectives.

✔

An adequate number of qualifiedpersonnel exist to perform functions inmanufacturing, packaging and QA.

✔

7.2 Hygienic Practices Score (8/8) 100.00%

Are there hygienic practices in place toprotect against contamination of food? ✔

Personnel should wear clean clothingsuitable for the manufacturing activity.Additional protective apparel, such ashead, face, hand, and arm coveringsshould be worn, when necessary.

✔

Any person, by medical examination orsupervisory observation, that is shown tohave, or appears to have, an illness, oropen lesions, by which there isreasonable possibility of food,food-contact surfaces, or food-packagingmaterials being contaminated, shall beexcluded from any operations untilcondition is corrected.

✔

Personnel shall be instructed to reportsuch conditions to supervisors. ✔

Designated areas outside of processingzones have been provided for clothingand other personal belongings (Jackets,cell phones, bags, radios, CD players,headsets, pagers).

✔

Consumption of food & beverages,chewing of gum, or the use of tobaccoproducts are strictly prohibited inprocessing areas.

✔


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Proper hand washing practices arereinforced with signs posted inbreakrooms, production areas, andwashrooms.

✔

Written procedures exist which addressand include the control and propersupervision of the above practices.

✔

7.3 Training Procedures Score (8/8) 100.00%

Have procedures been established andused for identifying training needs?Training procedure(s) shall exist for alllevels including part-time and temporarystaff, management, visitors,contract/construction personnel,consultants, government and customerauditors.

✔

Procedures address training schedulessuch as upon hire, future trainingrequirements, follow up and/orretraining frequencies.

✔

Training effectiveness is evaluated on aperiodic basis. ✔

Employee training covers general topicssuch as cGMP, sanitation, safety,environment, SOPs & MSDS. In addition,training is provided on specifc workinstructions, procedures, equipmentoperations, or as required to perform aspecific job function.

✔

Are qualifications and training recordsmaintained for all personnel? ✔

Are the qualifications and experiencerequirements for trainers defined in thetraining procedures?

✔

Training records must be maintained forall personnel and should include: Date,Topic, Name of Instructor, EmployeeSignatures, Tests, Quizzes, etc.

✔

Specific training requirements aredefined for each unique job descriptionor job function.

✔


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8 - Purchasing and Customer Service - 12/13 92.31%


8.1 Purchasing Score (3/4) 75.00%

Is there a system to notify customers ofdelivery days? ✔

How are they notified? E-mail, fax, phone,mail? Is this documented? ✔

All of the above but customer can chooseany method specific to them and cancelthe other methods.

What systems or processes are in placefor Cost of Quality (i.e. scrap, reduction,rework, commodity planning)?

✔

An up-to-date organization chart withnames/key personnel available. ✖

There was an employee who resignedtwo weeks ago and org chart is yet to beupdated.

8.2 Customer Service Score (3/3) 100.00%

Is there evidence of a Customer ServiceSystem? ✔

Company contact list. ✔

Is there a process for requesting samplesor information? ✔

Who receives and reviews ABGspecifications? N/A

8.3 General Score (6/6) 100.00%

Are there contingency plans for seriousproblems (fire, tornado, flood, etc.)? ✔

Is there a system to identify facility,machine, and operational needs for thefuture?

✔

An established complaint investigationand response program exists ✔

Do you have a recall procedure? ✔

Do you perform mock recalls? On whatfrequency? Have you performed onerecently? What were the results?

✔


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Do you have a documented stabilityprogram? ✔


- 21 -

Completion


Completion

Recommendation Make sure that org chart is immediately updated.

Full Name andSignature

Grace Stuff 18 Jul 2018 03:43 PM


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Appendix 1

conducted for food stuff - safetyculture · procedure for oos results, how is this ... (apis)...

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