ORAL DOSAGE FORM SOPs

1.0 PURPOSE

To provide a procedure for handling, investigations, documentations and dispositions of a market complaint along with applicable corrective and preventive actions.

2.0 SCOPE: 

Covers recording, investigating, reviewing, replying to customers and closing promptly all written and verbal complaints of a drug product

5.0 PROCEDURE:

5.1 Complaint Receipt:

5.1.1 All verbal or written complaints (along with samples received, if any) are received through one or of the following routes:

•     Contract giver (e.g. Marketing Authorization holder / Sponsor)
•     Marketing department
•     Customer
•     Regulatory agencies
•     Any employee of the company

5.1.2 All verbal /telephonic complaints received by any employee of the company and forwarded to QA shall be recorded in the customer complaint reporting form (Annexure – 1) and sent to QA Head for further investigations.

5.1.3 Any complaint of the products manufactured shall he handled by respective QA Head for further actions.

5.1.4 Any complaint samples received by Marketing Department shall be sent to the QA for further investigations.

5.1.5 Duly acknowledge receipt of the complaint to the complainant within 2 working days as per Annexure-2.

5.2 Logging and categorization:    Responsibility: QA

5.2.1 Allot a serial number as follows: JSA/MC/001/23 where ‘001’ indicates the first MC (market complaint) during the year, ‘23’ refers to the last two digits of the calendar year 2023.

5.2.2 Log the details in the market complaint log (Annexure-3) and fill the first six columns of the market complaint register. Simultaneously, fill the details of complaint and the sample, if received; in Part I of the complaint investigation Summary form (Annexure-4).

5.3 Preliminary Investigation:  Responsibility: QA

5.3.1 Evaluate the complaint based on the information received.

5.3.2 From the following areas, identify to which area the complaint is related. QA shall mention the CFT Members based on this identification.

• Analytical
•  Manufacturing
• Packing
•  Transit
• Storage

5.3.3 Obtain comments from the identified CFT members in the Part I of Complaint Investigation Form.

5.3.4 Initiate the process of preliminary investigation in consultation with relevant departments for all complaints.

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1.0 PURPOSE

To provide a structured and documented approach to be followed in case of a product recall     thereby minimizing risks to patients / consumers and adverse effects to the Organization.

2.0 SCOPE: 

Covers recall of products distributed from manufacturing Facility including samples for Clinical testing.  It does not include:

• Removal of time expired goods, if any.
• Removal of test samples / goods due to fall down in quality, safety or efficacy.

5.0 PROCEDURE:

5.1 RECEIPT AND ASSESSMENT OF PRODUCT INCIDENT INFORMATIONS: Responsibility – Quality Assurance Head

5.1.1 A product quality incident will trigger a recall.  This may arise out of either:

A) Self–identified (voluntary) reasons, e.g. results of ongoing stability studies.

Any such event requires notification to Chief Executive Officer/Quality Assurance Head.

                                                      (Or)

B) Due to any of the following situations:

• Market complaint from a customer. e.g. Adverse Drug experiences, Product mix-ups and label mix-ups, Physical and visual deterioration like significant discoloration, sedimentation, crystallization, etc. any significant quality defect, e.g. over-potency.
• Requests or mandates by regulatory agencies.
• Reports of adverse reactions to a particular batch of a product reported by a customer or regulatory agencies.

5.1.2 Follow SOP: SOP/QA/007 titled “Deviation Management” for recalls due to self identified reasons.

5.1.3 Fill the form “Recall decision tree” (Anexxure-1) in case of an identified needs for a product(s) recall and submit to the Chief Executive Officer along with detailed investigation reports / forms (e. g. health hazard evaluation form) to make a decision to recall.

5.1.4 Allot a serial number as follows: JSA/PR/001/23 where ‘001’ indicates the first PR during the year and continued serially. ‘23’refers to the last two digits of the calendar year 2023.

5.1.5 The filling of the recall decision tree form is facilitated by referring to the below mentioned  details:

5.2 Extent and nature of health hazard.

5.2.1 The classification is as follows:

 Class I defect:

5.2.1.1 It is a situation in which there is reasonable probability that the use of or exposure to a product will cause serious adverse health consequences or death. Few typical examples are as follows (but not limited to):

• Wrong product (label and contents are different products)
• Correct product but wrong strength, with serious medical consequences
• Incident(s) of product mix-up

Class II defect:

It is a situation in which use of or exposure to a product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.  Few typical examples are as follows (but not limited to):

• Missing text or figures in a product label.
• Missing or incorrect information – leaflets or inserts
• Microbial contamination of non- sterile product with medical consequences
• Non-conformance with specification (e.g. assay, stability, fill / weight)
• Insecure closure with serious medical consequences (e.g. child resistant containers).

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1.0 PURPOSE

To provide a procedure for conducting internal audits to verify compliance with the quality system procedures / SOPs and established standards.

2.0 SCOPE: 

It covers all the departments in the facility

5.0 PROCEDURE:

5.1 Internal audit shall be conducted with defined schedule for all departments.

5.1.1 INTERNAL AUDIT TEAM

The Internal Audit team consists of experts in their respective field and familiar with WHO-GMP norms from all departments.

5.1.2 Departmental head in consultation with QA Manager will propose the person for qualifying as a auditor.

5.1.3 QA Manager shall evaluate the person for Internal audit through oral interview based on the following criteria:

• Educational Qualification.
• Technical competency.
• Work Experience.
• WHO-GMP awareness/requirements.
• Regulatory awareness/requirements.
• Communication Skill.

5.2 Qualification of auditor for Internal Audit team

Following minimum parameter shall be required to qualify a person as an auditor.    

5.2.1 Apart from education and competency assessment, in case above mentioned parameters are not fulfilled, Quality Assurance Head can certify person as auditor based on below mentioned any one criteria:

• A person is certified auditor for QMS/GMP/Data Integrity from external agency.
• If person is part of vendor qualification team for minimum three audit.
• If person have been qualified for auditing by Quality Assurance Head or Corporate Quality through training/workshop on internal auditor and applicable regulatory guideline.              

5.2.2 Based on above parameter/criteria QA department shall prepare a checklist to qualify the person as auditor (Refer Annexure-6, Titled “Checklist for selection of Internal Auditor”).

5.2.3 After satisfactory evaluation by QA Manager, the Internal-auditor shall be certified to conduct Internal-auditor and the certificate shall be issued duly signed by QA Manager (Annexure –1 Titled “Certificate for approving the person for conducting  Internal audit”).

5.2.4 Requalification of Internal auditor shall be done after every three years ± 1 month /as per need.

• QA Assistant shall prepare a list of all qualified internal auditors (Annexure –2).

5.2.5 List of auditors (Annexure-2) shall be updated once in a year ± 1 month or change in lead auditor whichever is earlier

5.3  INTERNAL AUDIT PLAN:

5.3.1 Scheduled internal audit shall be conducted in order to

• To monitor the implementation and compliance with cGMP.
• To monitor the adherence to the SOPs/Policies.
• To review the proposed corrective measures and commitment of past regulatory/customer/internal audit compliance.

5.3.1 The internal audit team shall comprise of an auditor and at least one member (auditor) from Quality Assurance department).

5.3.2 Quality Assurance Department shall prepare the plan for the next year shall be prepared in the month of December of the previous year covering owing systems / areas (but not limited to):

• Quality Systems.
• Laboratory Control Systems
• Production Systems
• Packaging & Labeling Systems
• Facilities and Equipment Systems
• Materials Systems

5.3.3 This plan indicates the months of audits for every department (Annexure –3 Titled “Annual Internal audit plan”)

7.0 ANNEXURE

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1.0 PURPOSE

To provide guidelines for Preparation, Approval, Issuance, Archival and also to understand how the movement of BMR and BPR takes place between departments.

2.0 SCOPE: 

Scope of this SOP is to all BMRs and BPRs of products.

5.0 PROCEDURE:

5.1 PREPARATION OF BMR & BPR:

5.1.1 Draft BMR shall be prepared based on the following:

5.1.2 Master Formula Record (MFR).

5.1.3 Marketing order received from Plant Manager.

5.1.4 Monthly production plan from production department.

5.1.5 Draft BPR shall be prepared based on the (MPR).

5.1.6 The draft copy shall be counter checked by head of departments (production and QA) for correction and comments if any.

5.1.7 The same shall be incorporated in the Master BMR/BPR and print out of Master BMR/BPR and circulated for review and approval. After approval of QA-Head/Designee the BMR/BPR sent to responsible pharmacists for authorization. After Authorization signature of responsible pharmacists QA Stamp it as MASTER COPY.

5.1.7 Draft copy of BMR/BPR shall be destroyed once Master BMR/BPR is made effective. Store the Master BMR/BPR along with respective MFR/MPR using lock and key under QA custody.

5.1.8 Earlier Revisions of Master BMRs/BPRs (which is currently not in use) shall be stamped as SUPERSEDED in red.

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1.0 PURPOSE

To lay down the procedure for Batch Numbering and serial numbering for Drug Product manufactured in order to maintain batch Quality, Identity and traceability.

2.0 SCOPE: 

This SOP is applicable for all Drug product manufactured in the facility

5.0 PROCEDURE:

  5.1 BATCH NUMBERING SYSTEM:

5.2 Batch numbering for drug products intended shall be designed with respect to the following format: Product Code/YY/XXX.

• Use First Two Charterer of Product Code
• YY stands for last digit of the year in which batch manufactured)
• XXX stands for batch number, the first batch of each product shall start with 001.       

5.3 Every drug product batch number shall start with 001 by next New Year.

5.3.1 SERIAL NUMERING OF BMR:

• Serial number of BMR is allotted for the BMR of drug product manufactured at site.

5.3.2 BMRs shall serially number with respect to the following format: BMR/XXX/YY/ZZZ-RX.

• The serial number consists of 17 characters.
• The three characters (BMR) stand for Batch Manufacturing Record followed by “/”
• The Next three character (XXX) are the First three alphabet of Product Name and followed by “/”.
• The Next Two Character (YY) are represent the last numeric of the year in which BMR is prepared and followed by “/”.
• The Next three character (ZZZ) are the serial no. start from the 001 and followed by “-”.
• The Next Two Character (RX) is representing the Revision(R) and X is the number start with “0” for new BMR and R1 for first revision and so on.
• This serial number shall be allotted at the time of BMR made effective/Master.

5.4 SERIAL NUMBERING OF BPR:

• The serial number consists of 17 characters.
• The three characters (BPR) stand for Batch Packing Record followed by “/”
•   The Next three character (XXX) are the First three alphabet of Product Name and followed by “/”.
• The Next Two Character (YY) are represent the last numeric of the year in which BPR is prepared   and followed by “/”.
• The Next three character (ZZZ) are the serial no. start from the 001 and followed by “-”.
• The Next Two Character (RX) is representing the Revision(R) and X is the number start with “0” for new BPR and R1 for first revision and so on.
•   This serial number shall be allotted at the time of BPR made effective/Master

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1.0 PURPOSE

To provide a procedure for label control

2.0 SCOPE: 

This procedure  is applicable for label control in all departments.

5.0 PROCEDURE:

5.1 Labels include:

5.1.1 Raw material tags: these include quarantine label, release label, reject label.

5.1.2  Areas labels: these include restricted access label, status boards.

5.1.3  Equipment labels / In process labels: this includes status labels, product labels, cleaning status labels.

5.2 Upon receipt labeling materials, must be examined and acceptance activities performed to assure conformance of the label as per the defined formats. 

5.2.1 Serial number of BMR is allotted for the BMR of drug product manufactured at site.

5.2.2   BMRs shall serially number with respect to the following format: BMR/XXX/YY/ZZZ-RX.

5.2.3 Issuance of the label should be to the user department by QA and it should be bearing the effective format No. which represents that label is of the current in use version eg: Daily balance verification status.

5.2.4 QA department shall distribute the label to the respective department.    

5.2.5 QA department should fill the distribution details in the distribution records.

5.2.6 QA staff is responsible for issuing the status labels when a material has been approved or rejected.

5.2.7 Labels shall be signed at the time of affixing them by the department representative

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1.0 PURPOSE

To provide detailed procedure for managing artworks for all printed packaging materials in order to ensure regulatory/manufacturing/customer compliance.

2.0 SCOPE:

SOP Covers preparation, checking, approval, issuance, retrieval & destruction of Artwork of printed packaging materials namely labels, cartons, catch covers, pack inserts, foils etc., when a new artwork is introduced and when existing artwork is revised. 

5.0 PROCEDURE:

5.1 New Artwork initiation for commercial supplies:

5.1.1 Marketing shall give the request of preparation of artwork as per SOP.

5.1.2 On receipt of the request PDC initiates the artwork development.

5.1.3 PDC shall obtained the text matter in the format given in Annexure 1 from RA/MKT incase text mater not available either from customer or dossier.

5.1.4 Artwork preparation of the new product shall be initiated by PDC based on input obtained from   MKT/RA/Customer.

5.1.5 In consultation with the concern person in PDC technical team, the designer shall prepare the layout of artwork including the dimension and other technical aspects.

5.1.6 In case of the artwork is prepared for a customer, the design/existing artwork soft copy etc., if   receive from customer, shall be used as input to prepare the design of artwork.

5.1.7 If the artwork is prepared by customer, the soft copy of the same shall be used as input of finalize artwork as per internal requirements.

5.1.8 A unique item code shall be allotted to each printed packaging materials.

5.1.9 Based on the specific requirement from the customer, the item code shall be put on the artwork details label only and shall not appear on printed packaging material.

5.1.10 The printed packaging material shall also be incorporate with the relevant coding system such as Pharmacode, Barcode in their relevant formats if applicable.

5.1.11 Sufficient space for the batch coding margins shall be provided in the artwork of printed packaging material suitable for different method of coding such as Embossing, Stereo printing, etc.

5.1.12 The relevant details of artwork shall be filled by PDC in the “Artwork Detail Label “as per  Annexure 3.

5.1.13 Only native files shall be used for developing of an artwork.

5.1.14 Artwork review and approval process shall be performed as soft copy through mail.

5.1.15 In case of any emergencies or if the network disconnects the artwork review and approval    Process shall be followed through hard copy system.

 5.2 PREPERATION, REVIEW AND APPROVAL OF ARTWORK

5.2.1 After preparation of artwork designer shall check the artwork signed under the prepared by column &forward to the person reviewing.

5.2.2 In PDC the person reviewing the artwork shall also check the artwork as per checklist signed under Reviewed by column and forward to MKT.

5.2.3 Marketing shall check the artwork as per the checklist, signed under the reviewed by column and forward to Plant Head.

5.2.4 PDC shall send the artwork reviewed by MKT and Plant head for approval.

5.2.5 Plant QA shall also approve the artwork as per the checklist, signed under the approved by column.

5.2.6 QA shall kept the MASTER COPY with QA custody and CONTROLLED COPY issued to PDC, SCM and QC as per the Documents Distribution record Annexure 04. 

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1.0 PURPOSE

To provide a procedure for minimum technical agreements of contracting parties with respect to quality, safety and regulatory compliance.

2.0 SCOPE:

This procedure is applicable for all activities which directly or indirectly affect the quality of product    produced. This includes, but not limited to the following:

• External service providers
• Starting material suppliers
• All Third party

5.0 PROCEDURE:

5.1 When a service is sourced from CG to CA, it is essential that there shall be clear understanding, written documented by both CG and CA of all technical, safety, quality agreements, on the responsibility.

5.2 Quality agreement for external service provider:

5.2.1 A copy of relevant SOP and responsibility matrix shall be given to service provider to meet the quality requirement. Responsibility matrix shall be jointly signed by the CG and CA

5.3 Quality agreement as CG or CA: The quality agreement may include, but not limited to, the following contents on case to case basis:

• Introduction
• list of products along with site of manufacturing
• agreement on allocation of GMP responsibilities
• communication contacts
• change control
• deviation/Investigation
• supplier audit
• product presentations and specifications
• artwork, labeling, packing requirements
• packing and shipping
• manufacturing, packing, in-process controls, quality control of products
• batch numbering
• manufacturing, in-process testing and quality control
• sample retention batch rejection
• reprocess/rework
• complaint handling
• validation/qualification
• documentation / records
• batch release responsibility
• periodic regulatory report
• stability testing
• recall/field alerts
• retention period
• methods/specification/protocols/reports
• product quality review
• training /qualification
• Calibration and Preventive maintenance program
• Laboratory analysis
• OOS
• Right to audit
• Warehousing, shipping and transportations
• Sharing of regulatory audits findings
• Bulk products testing and release finish products testing and release
• Distribution
• Post marketing surveillance
• Batch release documents marketing authorization
• Regulatory/customer requirements of country where product is sold
• Approval of quality agreement
• Confidentiality and restriction of use
• terms of quality agreement and final approval

5.4 Any change or modifications to the information contained in the agreement shall be authorized in writing by both the parties in advance with mutual consent.

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1.0 PURPOSE

The objective of this SOP is to define the procedure to be followed for Process Perfromance Qualification (Process Validation) of drug products so that they are produced with meeting all the predefined attributes and quality parameters and the process is capable of consistently delivering quality products. This involves the collection and evaluation of data, from the process design stage through commercial production to establish scientific evidence that the process is capable of consistently delivering quality products.

2.0 SCOPE

This SOP is applicable for Manufacturing and Packing Process Perfromace Qualification to be carried out for all type of dosage forms manufactured.

5.0 PROCEDURE

Process Validation involves a series of activities taking place over the lifecycle of the product and process. These activities are described in three stages.

5.1 Process Design Stage (Stage 1): Involves designing the manufacturing process suitable for routine commercial manufacture, based on knowledge gained through development & scale up activities, so as to deliver product that meets the Pre-defined critical quality attributes.

5.2 Process Qualification Stage (Stage 2): Involves completion of prerequisite qualification checks for facility, equipment, utilities and personnel, followed by performance qualification of the process to confirm whether it is capable of reproducibly yielding quality product at commercial scale.

5.3 Continued Process Verification Stage (Stage 3): This is documented evidence for assurance which shows that the product is within specified limit of predetermined quality aspects and the process is within control during commercial manufacturing to continuously produce quality product.

It involves generating on-going assurance that the process remains in a state of control during routine commercial manufacture.

Remark: Process design stage (Stage I) is not applicable, when new product is introduced into the facility as a site transfer product from another site

5.4 Stage 1 : Process Design

5.4.1 F & D shall design a commercial manufacturing process for drug product in such a way that it can consistently deliver product that meets its predefined quality attributes.

5.4.2 F & D shall do all development activities as per QbD approach. Documentation of all development activities shall be carried out as per good documentation practice.

5.4.3 F & D shall take development batches or laboratory batches for process design using key inputs from quality target product profile.

5.4.4 Design of Experiment (DOE) studies shall be carried out for establishing ranges of incoming component quality, quantity, process parameters and in-process material quality attributes.

5.4.5 F & D shall define design space, PAR (Proven Acceptable Range) and NOR (normal operating range) based on development study and same shall be mentioned in product development report

5.4.6 F & D shall consider existing manufacturing technology / machine / environmental conditions for manufacturing of exhibit batches and future commercial batches or propose new technology/ machines/ environmental conditions for execution for exhibit batches and future commercial batches.

5.4.7 F & D shall decide representative scale up batch which may not be the same as commercial batch based on the product/ process requirement for estimation of process variability, to evaluate process parameters and prediction of performance of the commercial process.

5.4.8 F & D shall identify all the critical material attributes, critical quality attributes, critical process parameters and its control strategies based on risk assessment and same shall be mentioned in product development report for reference to manufacturing department.

5.4.9 Once the product formula and process is finalized; F & D shall take exhibit batch or submission batch as per respective regulatory requirements.

5.4.10 If exhibit batch or submission batch is planned as validation batches; requirements mentioned in stage 2, Process Qualification, shall be fulfilled.

5.4.11 Before starting of stage 2 Process Qualification; if PPQ batches are expected to have different batch size and equipment train as compared to exhibit batches; engineering batch having same batch size of proposed PPQ batches and same equipment train shall be taken by manufacturing department to verify the suitability of equipment train and to finalize the limit of CPP in batch manufacturing record of PPQ batches.

5.4.12 Manufacturing department shall prepare BMR for manufacturing of engineering batch and same shall be approved by QA before manufacturing of engineering batch.

5.4.13 If the specified range of any critical process parameter is within the equipment variability the same shall not be challenged. In case if the specified range is more than the equipment variability then the range shall be challenged for scale dependent parameter in scale up or engineering batches. Scale independent parameters shall be optimized at lab scale.

5.4.14 Knowledge gained from scale up batch, exhibit batch and engineering batch shall be used in preparation of BMR for commercial PPQ batches.

5.4.15 F & D shall provide following data and documents to manufacturing site for the preparation of commercial batch manufacturing records for stage 2 (i.e. Process Qualification) of process validation. (but not limited to):

• Product development report containing CMA (critical material attributes), CQA (critical quality attributes), CPP (critical process parameters), critical process steps, environmental conditions required for manufacturing, critical in process controls etc.
• Data supporting higher and lower ranges for scale dependent critical process parameters shall be established through DOE or scale up batches
• Risk assessment on the manufacturing process to identify the risk associated in the process and the steps taken to mitigate the same.
• Developed cleaning procedure of manufacturing equipment
• Scale up batch report  based on a protocol with identified CQA and equipment operating parameters for scale dependent critical process parameters including ancillary equipment with range wherever applicable
• Feasibility of manufacturing process and analytical method
• Hold Time Data (Chemical and Physical)
• Establish ranges for scale dependent critical process parameters by challenging in scale up batch. Note: If ranges are not established during the challenge study, engineering batches shall be once again executed with revised range by challenging.
• Establish cleaning procedure.

5.4.16 Analytical Method Validation and transfer report (Analytical method shall be validated and transferred to site before execution of exhibit batches)

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1.0 PURPOSE

To provide a procedure for establishing documented evidence that the cleaning methods used in cleaning the equipment, consistently and effectively removes the previous product below its predefined acceptance criteria. The SOP also provides a methodology to prepare a cleaning validation program for the facilities for the management of cleaning validation and the documentation involved.

2.0 SCOPE: 

This SOP is applicable to all drug products manufactured at site.

5.0 PROCEDURE:

5.1 The cleaning validation program shall primarily address the cross contamination of active ingredient(s) of previous product into next product by means of sharing common equipment and accessories like sampling rod, sampling dyes, scoops, etc,  contact surfaces. In accordance with this, all equipment’s and accessories that have product contact surfaces shall be brought into the scope of cleaning validation. Special emphasis shall be given to cleaning procedure requirements (ease if cleaning, inspection etc.) as part of design requirement.

5.2 Consideration shall also be given to other equipment’s or areas where there is greater risk of cross contamination exist.

5.3 The Dedicated equipment’s, accessories or facilities need not be subjected for comprehensive cleaning validation program. The cleaning validation approach in such cases shall be described in the specific protocol.

5.4 Types of cleaning procedures

5.4.1 The cleaning procedures are divided into two types based on the extent of cleaning.

5.4.2 Cleaning during campaign (also called as Serial cleaning)          

5.4.3 This type of cleaning is performed during following circumstances and is applicable only for non- sterile products:

• Cleaning between batches of same product (with same or different batch sizes)
• Cleaning between batches when changing over from lower strength to higher strength of the same product (& color)
• Cleaning at the end of the day

5.5 Cleaning during product change over (also called as Non-Serial cleaning)

      This type of cleaning is performed during following circumstances:

• Cleaning between batches of different product (with same or different batch sizes)
• Cleaning between batches when changing over from higher strength to lower strength
• Cleaning between batches when the color is different
• Cleaning after maintenance activity
• Cleaning after the equipment exceeds predefined hold time (dirty equipment or clean equipment)
• Cleaning after execution of maximum number of allowable batches during campaign (serial cleaning)

5.6 The cleaning validation program shall be managed using matrix approach.

5.7 All the facilities within the scope of the SOP shall have cleaning validation matrix. Single facility    may have multiple matrixes based on the product usage pattern or dosage form for the specified area for which the matrix is applicable. Example: Capsules manufacturing area, tablet manufacturing, Liquid Manufacturing are and Packaging area

• On individual equipment or on equipment train, matrix shall be prepared to identify worst case   product, including Product name / Generic name, Active Ingredient name (API), Label Claim,          Single Therapeutic Dose, Solubility Profile, LD50, but not limited to this/ The matrix for selection   worst case product B (Subsequent manufactured product) shall be prepared to identify the product   B. The criteria for identification of worst case product B is calculate the ratio of Batch Size vs. Largest recommended daily dose (LRDD) and select the product which will have minimum ratio of Batch size vs. LRDD. The Product which will manufactured for Trial, Scale up, optimization purpose and  which will not commercially distributed in market shall not considered in the matrix of Product B selection. The Matrix for selection of worst case Product B (Subsequent manufactured Product)

5.8 The MACO limits shall be calculated which shall be:

•   Practical
•   Verifiable
•   Achievable
•   Scientifically sound

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